Impact of Vitamin D Suplementation in Clinical Outcome at Tuberculosis Spondylitis : Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Impact of Vitamin D Suplementation in Clinical Outcome at Tuberculosis Spondylitis : Randomized Controlled Trial Jainal Arifin, Muhammad Nasrum Massi, Karya Triko Biakto, Agussalim Bukhari, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4247144/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 3 You are reading this latest preprint version Abstract Mycobacterium tuberculosis (MTB) causes infectious bacterial disease. Most cases of musculoskeletal tuberculosis affect vertebrae which cause spinal tuberculosis (spondylitis), extrapulmonary tuberculosis. Vitamin D deficiency have higher risk in tuberculosis infection. Vitamin D had role in the activation processes on immune cell which eliminate tuberculosis infection. The aim of the study is to assess the impact of oral supplementation of serum vitamin D on clinical outcome in spinal tuberculosis. The study design is randomized controlled trial. Total partisipants is 36 samples. The inclusion criteria were spinal tuberculosis patients diagnosed with MRI and GenExpert. The exclusion criteria were pulmonary tuberculosis, partisipant with other chronic disease such as diabetes, autoimun, malabsorption syndrome. Vitamin D serum levels were measured by ELISA method. There is a significant increasing serum levels of vitamin D in the study group were observed after 4 and 8 supplementation (p< 0.05). On the assessment of ODI and VAS, it decrease significantly in the three groups after 8 weeks of vitamin D supplementation (p<0.05), but in group 10.000 IU also decrease ODI and VAS score significant after 4 weeks supplementation. Trial Registration This study had clinical trial approved by U.S National Library of Medicine (NCT05376189, May 17, 2022). Vitamin D Clinical Outcome Spinal Tuberculosis Figures Figure 1 Figure 2 Highlights Vitamin D deficiency is high risk to suffer tuberculosis infection Tuberculosis spondylitis has many severe complications. Supplementation with vitamin D can improve clinical outcomes in tuberculosis spondylitis Article Summary This study divided into 3 groups vitamin D supplementation in evaluating clinical condition aftar 4 and 8 weeks. This study suggest vitamin D supplementation to improve treatment of spondylitis tuberculosis. This study limited not evaluate effect vitamin D in immune response. This study not separate tuberculosis infection in multidrug resistant or not. INTRODUCTION Mycobacterium tuberculosis (MTB) causes an infectious bacterial disease, tuberculosis infection. Mycobacterium tuberculosis has enzyme-producing bacteria which highly aerobic, acid-resistant, and does not have proteolytics.( 1 ) It can be transmitted between humans through the respiratory system. Mostly affects the lungs, but can damage other organs. About 10 percent of people with tuberculosis infection that progress into active disease.( 2 ) Based on clinical manifestations, tuberculosis infection is divided into two types. There are pulmonary and extrapulmonary tuberculosis. Extrapulmunary tuberculosis involves organs other than the lungs ( 3 , 4 ). The most cases of skeletal tuberculosis affect vertebrae which cause spinal tuberculosis. Impairment the immune system because of chemotherapy, age factor, diabetes melitus, alcoholism, malnutrition, or HIV may have a higher risk to have tuberculosis infection ( 1 , 5 ). Vitamin D deficiency increased risk of infection with Mycobacterium tuberculosis ( 6 ). Study by Tang et al. showed vitamin D deficiency have high risk to spinal tuberculosis ( 7 ). Vitamin D in active form plays the role in the immune system to eliminate Mycobacterium Tuberculosis ( 8 ). Vitamin D also regulates the absorption of calcium. ( 9 , 10 ) Vitamin D enters the immune system against Mycobacterium Tuberculosis. Vitamin D helps immune cell in producing LL-37, which will induce fagolisosomes on Mycobacterium Tuberculosis ( 11 ). Study by Yuk JM et al, vitamin D induces autophagi in monocytes. Vitamin D can help innate immunity against Mycobacterium tuberculosis infection. It also prevent causing further damaged to tissues ( 12 ). Vitamin D can improve role of nitrogen Oxide (NO) and Reactive Oxygen Species (ROS) for agains tuberculosis infection ( 13 ). Exogenous Vitamin D regulates the apoptosis mediated by caspase without causing an inflammatory reaction ( 14 ). METHODS The study design was randomized controlled trial which assessed clinical outcome of spinal tuberculosis patient whom given vitamin D supplementation. The inclusion criteria were spinal tuberculosis patients diagnosed with MRI and GenExpert. The exclusion criteria were pulmonary tuberculosis, partisipant with other chronic disease such as diabetes, autoimun, malabsorption syndrome. All subjects are divided into three groups. Total participants is 36 samples, with double blinded intervention. The study group given oral vitamin D supplementation 10.000 IU daily and 5,000 IU daily and the control group. The participant chosen randomly by simple random sampling which meet the criteria. Oral vitamin D supplementation was started after spinal tuberculosis confirmed and anti tuberculosis drug given. Study start from July – December 2022. Before supplementation, the venous blood sample were taken from the partisipants. The samples will be taken again after 4 and 8 weeks of supplementation. It will be centrifuged for 15 minutes to take blood serum. The blood serum stored in a freezer at − 20 ◦C in laboratory and processed for ELISA method analysis. The clinical criteria was measured by two items, VAS score and ODI score. Oswestry Disability Index (ODI) which is a questionnaire filled out by the patient. It assesses the level of disability in activities of daily living in people with low back pain. The VAS is a pain intensity scale that is scored between 0 and 10. Statistical analysis using SPSS to analyze the data of participants. The statistical test is significant if the p-value < 0.05 RESULTS During the research period, 53 participants were assessed for eligibility, but only 41 participants met the inclusion criteria and were willing to participate in the research. There were 5 participants who did discontinued vitamin D supplementation because died or lost to follow-up during study. Total participants is 36 participants. They were given anti-tuberculosis drugs with oral supplementation vitamin D daily; 12 participants were placed in each group. Most participant is male (52.8%) and the age all participants was 36.0 ± 13.2. Most participants have an underweight body mass index (BMI 2 segments (+) (-) Normal Parese Normal Hypoesthesy 10.000 IU 6 (50.0) 6 (50.0) 9 (75.0) 3 (25.0) 6 (50.0) 6 (50.0) 4( 33.3) 8 (66.7) 5.000 IU 11 (91.7) 1 (8.3) 9 (75.0) 3 (25.0) 8 (66.7) 4 (33.3) 8 (66.7) 4 (33.3) 400 IU 10 (83.3) 2 (16.7) 4 (33.3) 8 (66.7) 4 (33.3) 8 (66.7) 5 (41.7) 7 (58.3) Total 27 (75.0) 9 (25.0) 22 (61.1) 14 (38.9) 18(50.0) 18(50.0) 17(43.6) 19(48.7) From neurological examination, the study found motoric in normal limit (50%), normal sensoric (47.2%) in the neurological examination. Based on MRI examination, about 75% of all participants had destruction of the vertebral body less than or equal to two segments. Most participants had abscess formation (61.1%) such as paravertebral abscess, psoass abscess. The data anaylisis showed the data distributed normally (p > 0.05). (Table 1 ) Figure B. Vitamin D serum before and after supplementation This study found significant differences in vitamin D levels in blood serum from the each groups. In control group, vitamin D level serum did not increase significantly from week 0 to week 8 (p = 0.786). In the both study groups, there was a significant increase from week 0 to weeks 4 and 8. There is a moderate correlation between Vitamin D on VAS (r = − .580) and ODI (r = − .492) scores after 8 weeks supplementation with vitamin D (p < 0.05) (Fig. 2). Table 2. VAS and ODI scores before and after supplementation Group P-value 10.000 IU 5.000 IU 400 IU ODI Score (Mean ± SD) Week 0 44.83± 17.81 (Severe) 51.00± 16.63 (Severe) 49.50± 17.37 (Severe) .569 Week 4 30.33± 9.90 (Moderate) 44.16± 14.90 (Severe) 44.50± 15.59 (Severe) .024* Week 8 21.33± 6.22 (Moderate) 35.16± 9.35 (Moderate) 39.00± 12.89 (Moderate) .001* Most participants who suffered tuberculosis spondylitis had severe disability (based on ODI scores). The average pain scale (based on VAS) is 4.55 ± 1.62. ODI scores in the three groups showed no significant difference before supplementation. ODI score found in each group before supplementation was found to have severe disability (41–60%). In the 10,000 IU dose group showed a decrease in ODI scores due to moderate disability (21–40%), while the other dose groups had severe disability after 4 weeks of supplementation. The ODI scores in all three groups indicated moderate disability after 8 weeks of supplementation. ODI scores have significant differences in the three groups after 4 and 8 weeks of intervention through the one-way anova test. The three groups showed a significant decrease in ODI scores from week 0 to weeks 4 and 8 on repeated anova trials. (Table 2 ) Table 3. VAS scores before and after supplementation Group p-value 10.000 IU 5.000 IU 400 IU VAS Score (Mean ± SD) Week 0 4.83± 1.46 (Moderate) 4.83± 1.99 (Moderate) 4.00± 1.34 (Moderate) .361 Week 4 2.58 ±0.79 (Mild) 3.33 ±1.37 (Moderate) 3.58 ± 1.44 (Moderate) .136 Week 8 1.50 ± 0.52 (Mild) 2.00 ± 0.73 (Mild) 2.91± 0.90 (Mild) .000* VAS scores found in each group before supplementation are obtained in the middle degree ( 4 – 6 ). After supplementation for 8 weeks, the three groups showed a decrease in VAS score to a mild degree ( 1 – 3 ). At weeks 0 and 4, VAS scores in the three groups showed no significant difference in the one-way anova test. There was a significant difference in VAS score (p = 0,000) in the three groups after 8 weeks of intervention. (Table 3 ) DISCUSSIONS The study group showed increased vitamin D level serum after 4 and 8 weeks. Oral supplementation of vitamin D 10,000 IU daily for 8 weeks can increase serum vitamin D levels in optimal concentration (> 50 ng/ml). It can improve immune systems.( 15 ) But in vitamin D concentrations > 100 ng/ml may be harmful. ( 16 ) In other studies suggest toxicity vitamin D if the concentration > 150 ng/ml. Vitamin D can influence musculoskeletal system in bone and mineral metabolism.( 17 ) Vitamin D had effecy in strenght of muscles. The activated form of vitamin D will binding to vitamin D receptors which found in muscle can enhance proliferation and diffentiation of muscles.( 18 , 19 ) Vitamin D affect muscle protein synthesis, neuromuscular control, and type II muscle fibers. Vitamin D receptor also involved in calcium signaling and myogenesis.( 19 , 20 ) Serum vitamin D levels increase after given oral vitamin D ( 21 , 22 ) In this study showed increases serum vitamin D level serum significantly after 4 and 8 weeks supplementation compared to the control group. Production of vitamin D can decrease caused by genetic, dark skin color, sunscreen, and limited sunlight exposure, or when cutaneous vitamin D synthesis decrease. ( 19 , 23 , 24 ) Malabsorption can also induce lower concentration of vitamin D ( 10 , 19 , 25 ). Vitamin D deficiency increased high risk of Mycobacterium tuberculosis infection ( 26 ). In a study by Tang et al. showed that vitamin D deficiency have high risk to spinal tuberculosis ( 7 ) Vitamin D level serum in latent tuberculosis infection lower than normsl people. Vitamin D may lower the risk of latent tuberculosis infection.( 27 ) Increase in TLR indicates an increased immune response to eliminate Mycobacterium tuberculosis.Vitamin D enhance activation of toll like receptor (TLR) on Mycobacterium antigen. It will give response for the immunce cell (macrophages and dendritic cells) to produce proinflammatory cytokines.( 28 ) Activation of the TLR2 and TLR4 induces apoptosis and necrosis in tuberculosis infection.( 29 ) Vitamin D cam affect proliferation and differentiation of immune system. Concentration level vitamin D to > 100 nmol/L can increase in TLR2 expression. Meanwhile decrease vitamin D < 100 nmol/L (p = 0.002) can decrease TLR2 expression in cytokine production. Optimal vitamin D concentration can improve TLR-2 expression and increase immune system to eliminate the infections.( 30 ) The supplementation vitamin D can be intoxication in high doses. Elevated serum vitamin D concentrations can induced hypercalcemia, neuropsychiatric disorder, gastrointestinal, cardiovascular, renal disorder and PTH suppression. The clinical manifestations are confusion, drowsiness, apathy, vomiting, abdominal pain, anorexia, constipation, hypertension, polyuria, polydipsia, hypercalciuria, nephrocalcinosis ( 31 – 33 ). There is no participant had an side effect during this study. The Oswestry Disability Index (ODI) score is one of the assessment tools used in patients with low back pain (LBP) to evaluate clinical patients subjectively. The Visual Analog Scale (VAS) is a pain scale used as a clinical parameter in this study. The results of the study showed that after vitamin D supplementation, ODI scores decreased significantly at weeks 4 and 8. VAS scores decreased in significance in 8 weeks. In the 10,000 IU dose study group, after 4 weeks of supplementation, showed decrease in the degree of disability based on the ODI score was found, from severe disability (44.83 ± 17.81) to moderate disability (30.33 ± 9.90). The pain felt in tuberculosis spondylitis patients is due to the pressure on the epidural which suppresses the theca and nerve roots, and spinal instability.( 34 ). Vitamin D combined with calcium supplementation in patients over the age of 60 can play a role in reducing the risk of pelvic fractures by up to 26%.( 35 ) This is different from the study conducted by Panwar et al., which showed no significant difference in serum vitamin D levels in patients with less functionality (Bartel index 12).( 36 ) This is also true in the study carried out by Fang et al., who found that after vitamin D administration for 8 weeks in tuberculosis spondylitis patients who are getting OAT, there was a significant decrease in VAS score and an improvement in the degree of spinal injury.( 8 ). Conclusion Supplementation with vitamin D can increase serum vitamin D to optimally act as an immunomodulator to increase the ability to eliminate infections. In addition, clinically, vitamin D is able to improve clinical presentation by lowering ODI and VAS scores in patients with spinal tuberculosis. Group dose 10.000 IU can increase vitamin D serum to optimal concentration levels in 8 weeks. This study suggests oral supplementation with vitamin D as an additional therapy to anti-tuberculosis drugs to treat spinal tuberculosis. Authors recommend further research to investigate role vitamin D in the immune system. Declarations Ethical Approval and Consent to participate This study had clinical trial approved by U.S National Library of Medicine (NCT05376189, May 17, 2022). Each participant gave written informed consent and agreed to participate in the study. The study protocol has been approved by Health Research Ethics Committee of Faculty of Medicine, Universitas Hasanuddin (No.216/UN4.6.4.5.31/PP36/2022, April 19, 2022). All participants have signed informed consent to agree participate in this study but the data will be restricted because it containing information that could compromise the privacy of research participants. Consent for publication All authors agree to publish the manuscript. Availability of data and materials The data of participants can attached but it will be restricted because it containing information that could compromise the privacy of research participants. Competing interests statement All authors have no conflicts of interest to declare. Funding Statement All research and publication were funded by all the authors. The authors do not involved any employer. There is no potential conflict of interest about funding. Author contributions Jainal Arifin- study concept design, data collection, data analysis and interpretation, writing the paper, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript. Muhammad Nasrum Massi - study concept design, data analysis and interpretation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript. Karya Triko Biakto - study concept design, data analysis and interpretation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript. Agussalim Bukhari - study concept design, data analysis and interpretation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript. Muhammad Andry Usman - study concept design, data interpretation, writing the paper, validation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript. Firdaus Hamid - study concept design, data interpretation, validation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript. Endy Adnan - study concept design, data interpretation, validation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript. Muhammad Phetrus Johan - study concept design, data interpretation, writing the paper, validation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript. Andi Alfian Zainuddin - study concept design, data interpretation, validation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript. Acknowlegments We would like to thank the laboratory staff of Hasanuddin University Medical Research Center for their technical support. 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J Am Acad Orthop Surg. 2012;20(3):123. Panwar A, Garg RK, Malhotra HS, Jain A, Singh AK, Prakash S, et al. 25-Hydroxy Vitamin D, Vitamin D Receptor and Toll-like Receptor 2 Polymorphisms in Spinal Tuberculosis: A Case-Control Study. Med (Baltim). 2016;95(17):e3418. Additional Declarations No competing interests reported. Supplementary Files CONSORT2010Checklist.docx Cite Share Download PDF Status: Under Review Version 1 posted Submission checks completed at journal 04 Jun, 2024 Editor assigned by journal 04 Jun, 2024 First submitted to journal 10 Apr, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4247144","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":310403402,"identity":"6882a762-d3a4-44fb-881d-061caf635765","order_by":0,"name":"Jainal 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University","correspondingAuthor":false,"prefix":"","firstName":"Muhammad","middleName":"Phetrus","lastName":"Johan","suffix":""},{"id":310403410,"identity":"a55fc3bd-bf08-4f5b-8e37-2d07bb3bcbf6","order_by":8,"name":"Andi Alfian Zainuddin","email":"","orcid":"","institution":"Hasanuddin University","correspondingAuthor":false,"prefix":"","firstName":"Andi","middleName":"Alfian","lastName":"Zainuddin","suffix":""}],"badges":[],"createdAt":"2024-04-10 11:46:41","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4247144/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4247144/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":58753034,"identity":"0609464c-33d8-43e6-8672-3bcc15054005","added_by":"auto","created_at":"2024-06-20 16:16:47","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":719513,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eStudy Flowchart\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"FigureAStudyFlowchart.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4247144/v1/80d4d4df1c2a6cc0a542ef50.jpg"},{"id":58753033,"identity":"2719aa4f-bf2c-478d-867e-8c93963c7981","added_by":"auto","created_at":"2024-06-20 16:16:47","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":90030,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eVitamin D serum before and after supplementation\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"FigureBvitaminD.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4247144/v1/c81d1f5740d0dce28c896b16.jpg"},{"id":58754239,"identity":"6ede6d0a-60b9-4dbf-8252-67d7d0a025d9","added_by":"auto","created_at":"2024-06-20 16:24:47","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1333128,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4247144/v1/f72f06f7-e49c-4312-9865-6e27b828dea1.pdf"},{"id":58753035,"identity":"c9ebc6fc-996f-4851-a743-546968ba5f88","added_by":"auto","created_at":"2024-06-20 16:16:47","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":163638,"visible":true,"origin":"","legend":"","description":"","filename":"CONSORT2010Checklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-4247144/v1/a9f98450624761ff6672540c.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eImpact of Vitamin D Suplementation in Clinical Outcome at Tuberculosis Spondylitis : Randomized Controlled Trial\u003c/p\u003e","fulltext":[{"header":"Highlights","content":"\u003cul\u003e\n \u003cli\u003eVitamin D deficiency\u0026nbsp;is\u0026nbsp;high\u0026nbsp;risk\u0026nbsp;to\u0026nbsp;suffer tuberculosis infection\u003c/li\u003e\n \u003cli\u003eTuberculosis spondylitis has\u0026nbsp;many severe complications.\u003c/li\u003e\n \u003cli\u003eSupplementation\u0026nbsp;with\u0026nbsp;vitamin D can improve clinical outcomes\u0026nbsp;in tuberculosis spondylitis\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eArticle Summary\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eThis study divided into 3 groups vitamin D supplementation in evaluating clinical condition aftar 4 and 8 weeks.\u003c/li\u003e\n \u003cli\u003eThis study suggest vitamin D supplementation to improve treatment of spondylitis tuberculosis.\u003c/li\u003e\n \u003cli\u003eThis study limited not evaluate effect vitamin D in immune response.\u003c/li\u003e\n \u003cli\u003eThis study not separate tuberculosis infection in multidrug resistant or not.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"INTRODUCTION","content":"\u003cp\u003e \u003cem\u003eMycobacterium tuberculosis\u003c/em\u003e (MTB) causes an infectious bacterial disease, tuberculosis infection. Mycobacterium tuberculosis has enzyme-producing bacteria which highly aerobic, acid-resistant, and does not have proteolytics.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) It can be transmitted between humans through the respiratory system. Mostly affects the lungs, but can damage other organs. About 10 percent of people with tuberculosis infection that progress into active disease.(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) Based on clinical manifestations, tuberculosis infection is divided into two types. There are pulmonary and extrapulmonary tuberculosis. Extrapulmunary tuberculosis involves organs other than the lungs (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). The most cases of skeletal tuberculosis affect vertebrae which cause spinal tuberculosis. Impairment the immune system because of chemotherapy, age factor, diabetes melitus, alcoholism, malnutrition, or HIV may have a higher risk to have tuberculosis infection (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Vitamin D deficiency increased risk of infection with Mycobacterium tuberculosis (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Study by Tang et al. showed vitamin D deficiency have high risk to spinal tuberculosis (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eVitamin D in active form plays the role in the immune system to eliminate Mycobacterium Tuberculosis (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Vitamin D also regulates the absorption of calcium. (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) Vitamin D enters the immune system against Mycobacterium Tuberculosis. Vitamin D helps immune cell in producing LL-37, which will induce fagolisosomes on Mycobacterium Tuberculosis (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). Study by Yuk JM et al, vitamin D induces autophagi in monocytes. Vitamin D can help innate immunity against Mycobacterium tuberculosis infection. It also prevent causing further damaged to tissues (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Vitamin D can improve role of nitrogen Oxide (NO) and Reactive Oxygen Species (ROS) for agains tuberculosis infection (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Exogenous Vitamin D regulates the apoptosis mediated by caspase without causing an inflammatory reaction (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e).\u003c/p\u003e "},{"header":"METHODS","content":"\u003cp\u003eThe study design was randomized controlled trial which assessed clinical outcome of spinal tuberculosis patient whom given vitamin D supplementation. The inclusion criteria were spinal tuberculosis patients diagnosed with MRI and GenExpert. The exclusion criteria were pulmonary tuberculosis, partisipant with other chronic disease such as diabetes, autoimun, malabsorption syndrome. All subjects are divided into three groups. Total participants is 36 samples, with double blinded intervention. The study group given oral vitamin D supplementation 10.000 IU daily and 5,000 IU daily and the control group. The participant chosen randomly by simple random sampling which meet the criteria. Oral vitamin D supplementation was started after spinal tuberculosis confirmed and anti tuberculosis drug given. Study start from July \u0026ndash; December 2022.\u003c/p\u003e \u003cp\u003eBefore supplementation, the venous blood sample were taken from the partisipants. The samples will be taken again after 4 and 8 weeks of supplementation. It will be centrifuged for 15 minutes to take blood serum. The blood serum stored in a freezer at \u0026minus;\u0026thinsp;20 ◦C in laboratory and processed for ELISA method analysis.\u003c/p\u003e \u003cp\u003eThe clinical criteria was measured by two items, VAS score and ODI score. Oswestry Disability Index (ODI) which is a questionnaire filled out by the patient. It assesses the level of disability in activities of daily living in people with low back pain. The VAS is a pain intensity scale that is scored between 0 and 10. Statistical analysis using SPSS to analyze the data of participants. The statistical test is significant if the p-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eDuring the research period, 53 participants were assessed for eligibility, but only 41 participants met the inclusion criteria and were willing to participate in the research. There were 5 participants who did discontinued vitamin D supplementation because died or lost to follow-up during study. Total participants is 36 participants. They were given anti-tuberculosis drugs with oral supplementation vitamin D daily; 12 participants were placed in each group. Most participant is male (52.8%) and the age all participants was 36.0\u0026thinsp;\u0026plusmn;\u0026thinsp;13.2. Most participants have an underweight body mass index (BMI\u0026thinsp;\u0026lt;\u0026thinsp;18).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eNeurological deficit in participants\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"9\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eDestruction Vertebral Body\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eAbscess Formation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003eMotoric\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c9\" namest=\"c8\"\u003e \u003cp\u003eSensoric\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026le;\u0026thinsp;2 segment\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;2 segments\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e(+)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e(-)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNormal\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eParese\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eNormal\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c9\"\u003e \u003cp\u003eHypoesthesy\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003e10.000 IU\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6 (50.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6 (50.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e9 (75.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e3 (25.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e6 (50.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e6 (50.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e4( 33.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e \u003cp\u003e8 (66.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003e5.000 IU\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e11 (91.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1 (8.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e9 (75.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e3 (25.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e8 (66.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e4 (33.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e8 (66.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e \u003cp\u003e4 (33.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003e400 IU\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e10 (83.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2 (16.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e4 (33.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e8 (66.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e4 (33.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e8 (66.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e5 (41.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e \u003cp\u003e7 (58.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e27 (75.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9 (25.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e22 (61.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e14 (38.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e18(50.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e18(50.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e17(43.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e \u003cp\u003e19(48.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eFrom neurological examination, the study found motoric in normal limit (50%), normal sensoric (47.2%) in the neurological examination. Based on MRI examination, about 75% of all participants had destruction of the vertebral body less than or equal to two segments. Most participants had abscess formation (61.1%) such as paravertebral abscess, psoass abscess. The data anaylisis showed the data distributed normally (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05). (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e \u003cp\u003e \u003cb\u003eFigure B. Vitamin D serum before and after supplementation\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThis study found significant differences in vitamin D levels in blood serum from the each groups. In control group, vitamin D level serum did not increase significantly from week 0 to week 8 (p\u0026thinsp;=\u0026thinsp;0.786). In the both study groups, there was a significant increase from week 0 to weeks 4 and 8. There is a moderate correlation between Vitamin D on VAS (r\u0026thinsp;=\u0026thinsp;\u0026minus;\u0026thinsp;.580) and ODI (r\u0026thinsp;=\u0026thinsp;\u0026minus;\u0026thinsp;.492) scores after 8 weeks supplementation with vitamin D (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05) (Fig.\u0026nbsp;2).\u003c/p\u003e \n\u003cp\u003e\u003cstrong\u003eTable 2. VAS and ODI scores before and after supplementation\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"634\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.305993690851736%\" rowspan=\"2\" style=\"width: 3.7937%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"11.67192429022082%\" valign=\"bottom\" style=\"width: 5.2327%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"68.61198738170347%\" colspan=\"9\" style=\"width: 29.6958%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGroup\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.410094637223974%\" rowspan=\"2\" style=\"width: 0.1282%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eP-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"14.538310412573674%\" valign=\"bottom\" style=\"width: 5.2327%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"27.897838899803535%\" colspan=\"3\" style=\"width: 9.8114%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e10.000 IU\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.68369351669941%\" colspan=\"3\" style=\"width: 9.9422%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e5.000 IU\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"28.88015717092338%\" colspan=\"3\" style=\"width: 9.9422%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e400 IU\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.320695102685624%\" rowspan=\"3\" style=\"width: 3.7937%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eODI Score (Mean \u0026plusmn; SD)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.268562401263823%\" style=\"width: 4.5132%;\"\u003e\n \u003cp\u003eWeek 0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.320695102685624%\" colspan=\"2\" style=\"width: 3.9246%;\"\u003e\n \u003cp\u003e44.83\u0026plusmn; 17.81\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.11216429699842%\" style=\"width: 5.8868%;\"\u003e\n \u003cp\u003e(Severe)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.42654028436019%\" colspan=\"2\" style=\"width: 4.2516%;\"\u003e\n \u003cp\u003e51.00\u0026plusmn; 16.63\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.480252764612954%\" style=\"width: 5.6252%;\"\u003e\n \u003cp\u003e(Severe)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.742496050552923%\" colspan=\"2\" style=\"width: 4.4478%;\"\u003e\n \u003cp\u003e49.50\u0026plusmn; 17.37\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.480252764612954%\" style=\"width: 5.6252%;\"\u003e\n \u003cp\u003e(Severe)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.42654028436019%\" colspan=\"2\" style=\"width: 2.8126%;\"\u003e\n \u003cp\u003e.569\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"11.32404181184669%\" style=\"width: 4.5132%;\"\u003e\n \u003cp\u003eWeek 4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.278745644599303%\" colspan=\"2\" style=\"width: 3.9246%;\"\u003e\n \u003cp\u003e30.33\u0026plusmn; 9.90\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.45993031358885%\" style=\"width: 5.8868%;\"\u003e\n \u003cp\u003e(Moderate)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.498257839721255%\" colspan=\"2\" style=\"width: 4.2516%;\"\u003e\n \u003cp\u003e44.16\u0026plusmn; 14.90\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.763066202090592%\" style=\"width: 5.6252%;\"\u003e\n \u003cp\u003e(Severe)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.846689895470384%\" colspan=\"2\" style=\"width: 4.4478%;\"\u003e\n \u003cp\u003e44.50\u0026plusmn; 15.59\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.763066202090592%\" style=\"width: 5.6252%;\"\u003e\n \u003cp\u003e(Severe)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.498257839721255%\" colspan=\"2\" style=\"width: 2.8126%;\"\u003e\n \u003cp\u003e.024*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"11.32404181184669%\" style=\"width: 4.5132%;\"\u003e\n \u003cp\u003eWeek 8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.278745644599303%\" colspan=\"2\" style=\"width: 3.9246%;\"\u003e\n \u003cp\u003e21.33\u0026plusmn; 6.22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.45993031358885%\" style=\"width: 5.8868%;\"\u003e\n \u003cp\u003e(Moderate)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.498257839721255%\" colspan=\"2\" style=\"width: 4.2516%;\"\u003e\n \u003cp\u003e35.16\u0026plusmn; 9.35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.763066202090592%\" style=\"width: 5.6252%;\"\u003e\n \u003cp\u003e(Moderate)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.846689895470384%\" colspan=\"2\" style=\"width: 4.4478%;\"\u003e\n \u003cp\u003e39.00\u0026plusmn; 12.89\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.763066202090592%\" style=\"width: 5.6252%;\"\u003e\n \u003cp\u003e(Moderate)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.498257839721255%\" colspan=\"2\" style=\"width: 2.8126%;\"\u003e\n \u003cp\u003e.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\u003cp\u003eMost participants who suffered tuberculosis spondylitis had severe disability (based on ODI scores). The average pain scale (based on VAS) is 4.55\u0026thinsp;\u0026plusmn;\u0026thinsp;1.62. ODI scores in the three groups showed no significant difference before supplementation. ODI score found in each group before supplementation was found to have severe disability (41\u0026ndash;60%). In the 10,000 IU dose group showed a decrease in ODI scores due to moderate disability (21\u0026ndash;40%), while the other dose groups had severe disability after 4 weeks of supplementation. The ODI scores in all three groups indicated moderate disability after 8 weeks of supplementation. ODI scores have significant differences in the three groups after 4 and 8 weeks of intervention through the one-way anova test. The three groups showed a significant decrease in ODI scores from week 0 to weeks 4 and 8 on repeated anova trials. (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \n\u003cp\u003e\u003cstrong\u003eTable 3. VAS scores before and after supplementation\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"611\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.656301145662848%\" rowspan=\"2\" style=\"width: 3.9717%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"12.111292962356792%\" valign=\"bottom\" style=\"width: 5.5467%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"67.43044189852701%\" colspan=\"9\" style=\"width: 29.4453%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGroup\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.801963993453356%\" rowspan=\"2\" style=\"width: 0.2972%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"15.22633744855967%\" valign=\"bottom\" style=\"width: 5.5467%;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd width=\"25.308641975308642%\" colspan=\"3\" style=\"width: 8.9021%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e10.000 IU\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"29.218106995884774%\" colspan=\"3\" style=\"width: 10.1347%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e5.000 IU\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.246913580246915%\" colspan=\"3\" style=\"width: 10.4086%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e400 IU\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.656301145662848%\" rowspan=\"3\" style=\"width: 3.9717%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVAS Score (Mean \u0026plusmn; SD)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.638297872340425%\" style=\"width: 4.7934%;\"\u003e\n \u003cp\u003eWeek 0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"7.6923076923076925%\" colspan=\"2\" style=\"width: 3.2869%;\"\u003e\n \u003cp\u003e4.83\u0026plusmn; 1.46\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.438625204582651%\" style=\"width: 5.6836%;\"\u003e\n \u003cp\u003e(Moderate)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.801963993453356%\" colspan=\"2\" style=\"width: 4.451%;\"\u003e\n \u003cp\u003e4.83\u0026plusmn; 1.99\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.438625204582651%\" style=\"width: 5.6836%;\"\u003e\n \u003cp\u003e(Moderate)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.129296235679215%\" colspan=\"2\" style=\"width: 4.5195%;\"\u003e\n \u003cp\u003e4.00\u0026plusmn; 1.34\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.92962356792144%\" style=\"width: 5.8891%;\"\u003e\n \u003cp\u003e(Moderate)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"10.801963993453356%\" colspan=\"2\" style=\"width: 3.013%;\"\u003e\n \u003cp\u003e.361\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"11.77536231884058%\" style=\"width: 4.7934%;\"\u003e\n \u003cp\u003eWeek 4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.514492753623188%\" colspan=\"2\" style=\"width: 3.2869%;\"\u003e\n \u003cp\u003e2.58 \u0026plusmn;0.79\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.768115942028986%\" style=\"width: 5.6836%;\"\u003e\n \u003cp\u003e(Mild)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.956521739130435%\" colspan=\"2\" style=\"width: 4.451%;\"\u003e\n \u003cp\u003e3.33 \u0026plusmn;1.37\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.768115942028986%\" style=\"width: 5.6836%;\"\u003e\n \u003cp\u003e(Moderate)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.318840579710145%\" colspan=\"2\" style=\"width: 4.5195%;\"\u003e\n \u003cp\u003e3.58 \u0026plusmn; 1.44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.31159420289855%\" style=\"width: 5.8891%;\"\u003e\n \u003cp\u003e(Moderate)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.956521739130435%\" colspan=\"2\" style=\"width: 3.013%;\"\u003e\n \u003cp\u003e.136\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"11.77536231884058%\" style=\"width: 4.7934%;\"\u003e\n \u003cp\u003eWeek 8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.514492753623188%\" colspan=\"2\" style=\"width: 3.2869%;\"\u003e\n \u003cp\u003e1.50 \u0026plusmn; 0.52\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.768115942028986%\" style=\"width: 5.6836%;\"\u003e\n \u003cp\u003e(Mild)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.956521739130435%\" colspan=\"2\" style=\"width: 4.451%;\"\u003e\n \u003cp\u003e2.00 \u0026plusmn; 0.73\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.768115942028986%\" style=\"width: 5.6836%;\"\u003e\n \u003cp\u003e(Mild)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.318840579710145%\" colspan=\"2\" style=\"width: 4.5195%;\"\u003e\n \u003cp\u003e2.91\u0026plusmn; 0.90\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.31159420289855%\" style=\"width: 5.8891%;\"\u003e\n \u003cp\u003e(Mild)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.956521739130435%\" colspan=\"2\" style=\"width: 3.013%;\"\u003e\n \u003cp\u003e.000*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e \u003cp\u003eVAS scores found in each group before supplementation are obtained in the middle degree (\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). After supplementation for 8 weeks, the three groups showed a decrease in VAS score to a mild degree (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). At weeks 0 and 4, VAS scores in the three groups showed no significant difference in the one-way anova test. There was a significant difference in VAS score (p\u0026thinsp;=\u0026thinsp;0,000) in the three groups after 8 weeks of intervention. (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e"},{"header":"DISCUSSIONS","content":"\u003cp\u003eThe study group showed increased vitamin D level serum after 4 and 8 weeks. Oral supplementation of vitamin D 10,000 IU daily for 8 weeks can increase serum vitamin D levels in optimal concentration (\u0026gt;\u0026thinsp;50 ng/ml). It can improve immune systems.(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) But in vitamin D concentrations\u0026thinsp;\u0026gt;\u0026thinsp;100 ng/ml may be harmful. (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) In other studies suggest toxicity vitamin D if the concentration\u0026thinsp;\u0026gt;\u0026thinsp;150 ng/ml. Vitamin D can influence musculoskeletal system in bone and mineral metabolism.(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) Vitamin D had effecy in strenght of muscles. The activated form of vitamin D will binding to vitamin D receptors which found in muscle can enhance proliferation and diffentiation of muscles.(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) Vitamin D affect muscle protein synthesis, neuromuscular control, and type II muscle fibers. Vitamin D receptor also involved in calcium signaling and myogenesis.(\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eSerum vitamin D levels increase after given oral vitamin D (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) In this study showed increases serum vitamin D level serum significantly after 4 and 8 weeks supplementation compared to the control group. Production of vitamin D can decrease caused by genetic, dark skin color, sunscreen, and limited sunlight exposure, or when cutaneous vitamin D synthesis decrease. (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e) Malabsorption can also induce lower concentration of vitamin D (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). Vitamin D deficiency increased high risk of Mycobacterium tuberculosis infection (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). In a study by Tang et al. showed that vitamin D deficiency have high risk to spinal tuberculosis (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e) Vitamin D level serum in latent tuberculosis infection lower than normsl people. Vitamin D may lower the risk of latent tuberculosis infection.(\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eIncrease in TLR indicates an increased immune response to eliminate Mycobacterium tuberculosis.Vitamin D enhance activation of toll like receptor (TLR) on Mycobacterium antigen. It will give response for the immunce cell (macrophages and dendritic cells) to produce proinflammatory cytokines.(\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e) Activation of the TLR2 and TLR4 induces apoptosis and necrosis in tuberculosis infection.(\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e) Vitamin D cam affect proliferation and differentiation of immune system. Concentration level vitamin D to \u0026gt;\u0026thinsp;100 nmol/L can increase in TLR2 expression. Meanwhile decrease vitamin D\u0026thinsp;\u0026lt;\u0026thinsp;100 nmol/L (p\u0026thinsp;=\u0026thinsp;0.002) can decrease TLR2 expression in cytokine production. Optimal vitamin D concentration can improve TLR-2 expression and increase immune system to eliminate the infections.(\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eThe supplementation vitamin D can be intoxication in high doses. Elevated serum vitamin D concentrations can induced hypercalcemia, neuropsychiatric disorder, gastrointestinal, cardiovascular, renal disorder and PTH suppression. The clinical manifestations are confusion, drowsiness, apathy, vomiting, abdominal pain, anorexia, constipation, hypertension, polyuria, polydipsia, hypercalciuria, nephrocalcinosis (\u003cspan additionalcitationids=\"CR32\" citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). There is no participant had an side effect during this study.\u003c/p\u003e \u003cp\u003eThe Oswestry Disability Index (ODI) score is one of the assessment tools used in patients with low back pain (LBP) to evaluate clinical patients subjectively. The Visual Analog Scale (VAS) is a pain scale used as a clinical parameter in this study. The results of the study showed that after vitamin D supplementation, ODI scores decreased significantly at weeks 4 and 8. VAS scores decreased in significance in 8 weeks. In the 10,000 IU dose study group, after 4 weeks of supplementation, showed decrease in the degree of disability based on the ODI score was found, from severe disability (44.83\u0026thinsp;\u0026plusmn;\u0026thinsp;17.81) to moderate disability (30.33\u0026thinsp;\u0026plusmn;\u0026thinsp;9.90). The pain felt in tuberculosis spondylitis patients is due to the pressure on the epidural which suppresses the theca and nerve roots, and spinal instability.(\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e). Vitamin D combined with calcium supplementation in patients over the age of 60 can play a role in reducing the risk of pelvic fractures by up to 26%.(\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e) This is different from the study conducted by Panwar et al., which showed no significant difference in serum vitamin D levels in patients with less functionality (Bartel index\u0026thinsp;\u0026lt;\u0026thinsp;12) compared to the group with good functionality (Bartel index\u0026thinsp;\u0026gt;\u0026thinsp;12).(\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e) This is also true in the study carried out by Fang et al., who found that after vitamin D administration for 8 weeks in tuberculosis spondylitis patients who are getting OAT, there was a significant decrease in VAS score and an improvement in the degree of spinal injury.(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e).\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eSupplementation with vitamin D can increase serum vitamin D to optimally act as an immunomodulator to increase the ability to eliminate infections. In addition, clinically, vitamin D is able to improve clinical presentation by lowering ODI and VAS scores in patients with spinal tuberculosis. Group dose 10.000 IU can increase vitamin D serum to optimal concentration levels in 8 weeks. This study suggests oral supplementation with vitamin D as an additional therapy to anti-tuberculosis drugs to treat spinal tuberculosis. Authors recommend further research to investigate role vitamin D in the immune system.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthical Approval and Consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study had clinical trial approved by U.S National Library of Medicine (NCT05376189, May 17, 2022). Each participant gave written informed consent and agreed to participate in the study. The study protocol has been approved by Health Research Ethics Committee of Faculty of Medicine, Universitas Hasanuddin (No.216/UN4.6.4.5.31/PP36/2022, April 19, 2022). All participants have signed informed consent to agree participate in this study but the data will be restricted because it containing information that could compromise the privacy of research participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors agree to publish the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data of participants can attached but it will be restricted because it containing information that could compromise the privacy of research participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;All authors have no conflicts of interest to declare.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll research and publication were funded by all the authors. The authors do not involved any employer. There is no potential conflict of interest about funding.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eJainal Arifin- study concept design, data collection, data analysis and interpretation, writing the paper, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript.\u003c/p\u003e\n\u003cp\u003eMuhammad Nasrum Massi - study concept design, data analysis and interpretation, reviewing of \u0026nbsp;the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript.\u003c/p\u003e\n\u003cp\u003eKarya Triko Biakto - study concept design, data analysis and interpretation, reviewing of \u0026nbsp;the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript.\u003c/p\u003e\n\u003cp\u003eAgussalim Bukhari - study concept design, data analysis and interpretation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript.\u003c/p\u003e\n\u003cp\u003eMuhammad Andry Usman - study concept design, data interpretation, writing the paper, validation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript.\u003c/p\u003e\n\u003cp\u003eFirdaus Hamid - study concept design, data interpretation, validation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript.\u003c/p\u003e\n\u003cp\u003eEndy Adnan - study concept design, data interpretation, \u0026nbsp;validation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript.\u003c/p\u003e\n\u003cp\u003eMuhammad Phetrus Johan - study concept design, data interpretation, writing the paper, validation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript.\u003c/p\u003e\n\u003cp\u003eAndi Alfian Zainuddin - study concept design, data interpretation, validation, reviewing of the manuscript, final approval of the manuscript to be published, and agreement to be an accountable manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowlegments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank the laboratory staff of Hasanuddin University Medical Research Center for their technical support. We would also like to express our gratitude to all study participants. All authors contributed to preparing this manuscript. We had the translation ourselves.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eRajasekaran S, Kanna RM, Shetty AP. Pathophysiology and Treatment of Spinal Tuberculosis. JBJS Rev [Internet]. 2014 Sep 23 [cited 2023 Aug 15];2(9). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://journals.lww.com/01874474-201409000-00004\u003c/span\u003e\u003cspan address=\"https://journals.lww.com/01874474-201409000-00004\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBloom BR, Atun R, Cohen T, Dye C, Fraser H, Gomez GB et al. Tuberculosis. In: Holmes KK, Bertozzi S, Bloom BR, Jha P, editors. Major Infectious Diseases [Internet]. 3rd ed. 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Med (Baltim). 2016;95(17):e3418.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"bmc-complementary-medicine-and-therapies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bcam","sideBox":"Learn more about [BMC Complementary Medicine and Therapies](https://bmccomplementmedtherapies.biomedcentral.com/)","snPcode":"","submissionUrl":"","title":"BMC Complementary Medicine and Therapies","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Vitamin D, Clinical Outcome, Spinal Tuberculosis","lastPublishedDoi":"10.21203/rs.3.rs-4247144/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4247144/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003eMycobacterium tuberculosis\u003c/em\u003e (MTB) causes infectious bacterial disease. Most cases of musculoskeletal tuberculosis affect vertebrae which cause spinal tuberculosis (spondylitis), extrapulmonary tuberculosis. Vitamin D deficiency have higher risk in tuberculosis infection. Vitamin D had role in the activation processes on immune cell which eliminate tuberculosis infection. The aim of the study is to assess the impact of oral supplementation of serum vitamin D on clinical outcome in spinal tuberculosis. The study design is randomized controlled trial. Total partisipants is 36 samples. The inclusion criteria were spinal tuberculosis patients diagnosed with MRI and GenExpert. The exclusion criteria were pulmonary tuberculosis, partisipant with other chronic disease such as diabetes, autoimun, malabsorption syndrome. Vitamin D serum levels were measured by ELISA method. There is a significant increasing serum levels of vitamin D in the study group were observed after 4 and 8 supplementation (p\u0026lt; 0.05). On the assessment of ODI and VAS, it decrease significantly in the three groups after 8 weeks of vitamin D supplementation (p\u0026lt;0.05), but in group 10.000 IU also decrease ODI and VAS score significant after 4 weeks supplementation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Registration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study had clinical trial approved by U.S National Library of Medicine (NCT05376189, May 17, 2022).\u003c/p\u003e","manuscriptTitle":"Impact of Vitamin D Suplementation in Clinical Outcome at Tuberculosis Spondylitis : Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-06-20 16:16:42","doi":"10.21203/rs.3.rs-4247144/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"checksComplete","content":"","date":"2024-06-04T10:07:50+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-06-04T10:07:50+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Complementary Medicine and Therapies","date":"2024-04-10T11:45:28+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
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