Oral Vitamin D and Toll Like Receptor in Spondylitis Tuberculosis
NCT ID: NCT05376189
Last Updated: 2022-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
37 participants
INTERVENTIONAL
2022-07-01
2023-02-01
Brief Summary
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The toll-like receptor is an essential receptor that stimulates the innate immunity response. In tuberculosis, toll-like receptors, particularly the TLR-2, and TLR-4 are crucial in recognizing various ligands with a lipoprotein structure in the bacilli. Vitamin D deficiency leads to lower expression of these receptors, Hence the immune response against Mycobacterium tuberculosis will be altered. Various studies addressed the importance of vitamin D supplementation in pulmonary tuberculosis but the effect of vitamin D in extrapulmonary tuberculosis, particularly spondylitis tuberculosis is not sufficiently identified.
Objectives:
To assess the effect of oral vitamin D supplementation on the expression of TLR-2, TLR-4, and clinical outcomes in spondylitis tuberculosis patients.
Methodology:
This study proposes a randomized clinical trial of oral vitamin D supplementation in spondylitis tuberculosis patients. Multiple arms will be established with different doses and control groups. The outcome of interest includes the clinical outcomes, the expression of TLR-2, and TLR 4
Hypothesis :
It is assumed that oral supplementation of Vitamin D will increase the activation of Toll-Like Receptors and improves the clinical condition of Spondylitis Tuberculosis patients
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Detailed Description
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Patients with spondylitis tuberculosis without the involvement of lung and other extrapulmonary infection
Design:
Randomized Clinical Trial with 3 arms
Primary Intervention:
Standardized Tuberculosis treatment with oral Vitamin D3 Supplementation daily for 8 weeks
Outcome:
1. Toll-Like Receptors (TLR) 2 and 4 levels from the blood sample, measured using Enzyme-linked Immunoassay (ELISA).
2. Clinical Evaluation with Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI).
The outcomes will be measured three times at 4-week intervals (baseline, week 4, and week 8)
Sample Size and Recruitment Participants will be recruited from hospitals and allocated by simple randomization
Biological Sample and consent
1. Participants are aware that clinical data collection and biological samples will be obtained by researchers. This is mentioned in informed consent prior to study recruitment
2. Blood sample will be obtained in a standardized phlebotomy procedure and will not be retained after the study is finish.
Hypothesis Sample Size Calculation:
The trial will be designed to compare 2 experimental treatments to a shared control arm.
The sample size was estimated based on the mathematical calculation by a study below Grayling, M.J et al
With the assumption of :
1. K=2 experimental treatments will be included in the trial.
2. A significance level of α=0.05 will be used, in combination with no multiple comparison correction.
3. The event rate in the control arm will be assumed to be: λ0=5.
4. The marginal power for each null hypothesis will be controlled to level 1-β=0.8 under each of their respective least favorable configurations.
5. The interesting and uninteresting treatment effects will be δ1=2.5 and δ0=0 respectively.
6. The target allocation to each of the experimental arms will be the same as the control arm.
7. The sample size in each arm will not be required to be an integer.
Hence total sample should be 37 participants
Proposed Statistical Analysis
1. Descriptive Statistics
2. Bivariate Analysis
3. The study will apply intention-to-treat analysis
4. Linear Mixed model to measure the effect of intervention adjusted by fixed and random factors.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control Group
This group will be given standardized tuberculosis drug with 400 IU of oral Vitamin D3
400 IU
An Oral Vitamin D3 400 IU will be given once daily for a total of 8 weeks
Fixed Drug Combination
Standard Tuberculosis Regimen in a form of Fixed Drug Combination (FDC) given for Spondylitis Tuberculosis.
Moderate Dose
This group will be given standardized tuberculosis drug with 5000 IU of oral Vitamin D3
5000 IU
An Oral Vitamin D3 5000 IU will be given once daily for a total of 8 weeks
Fixed Drug Combination
Standard Tuberculosis Regimen in a form of Fixed Drug Combination (FDC) given for Spondylitis Tuberculosis.
High Dose
This group will be given standardized tuberculosis drug with 10000 IU of oral Vitamin D3
10000 IU
An Oral Vitamin D3 10000 IU will be given once daily for a total of 8 weeks
Fixed Drug Combination
Standard Tuberculosis Regimen in a form of Fixed Drug Combination (FDC) given for Spondylitis Tuberculosis.
Interventions
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400 IU
An Oral Vitamin D3 400 IU will be given once daily for a total of 8 weeks
5000 IU
An Oral Vitamin D3 5000 IU will be given once daily for a total of 8 weeks
10000 IU
An Oral Vitamin D3 10000 IU will be given once daily for a total of 8 weeks
Fixed Drug Combination
Standard Tuberculosis Regimen in a form of Fixed Drug Combination (FDC) given for Spondylitis Tuberculosis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Level of Total Vitamin D \<50 nmol/L at baseline
Exclusion Criteria
2. Participants with osteoporosis, malignancy, cardiovascular disease, diabetes mellitus, and autoimmune disease
3. Participants with liver and kidney dysfunction
4. Participants who received Vitamin D prior to enrollment
19 Years
50 Years
ALL
No
Sponsors
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Hasanuddin University
OTHER
Responsible Party
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Bumi Herman
Assitant Lecturer
Principal Investigators
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Jainal Arifin, MD
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Nasrum Massi, MD. Ph.D
Role: STUDY_CHAIR
Hasanuddin University
Firdaus Hamid, MD. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Andi Alfian Zainuddin, MD. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Locations
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Wahidin Sudirohusodo General Hospital
Makassar, South Sulawesi, Indonesia
Countries
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Central Contacts
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Facility Contacts
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References
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Grayling MJ, Wason JM. A web application for the design of multi-arm clinical trials. BMC Cancer. 2020 Jan 31;20(1):80. doi: 10.1186/s12885-020-6525-0.
Tang L, Liu S, Bao YC, Gao RX, Han CF, Sun XC, Zhang WL, Feng SQ. Study on the relationship between vitamin D deficiency and susceptibility to spinal tuberculosis. Int J Surg. 2017 Aug;44:99-103. doi: 10.1016/j.ijsu.2017.05.077. Epub 2017 Jun 16.
Panwar A, Garg RK, Malhotra HS, Jain A, Singh AK, Prakash S, Kumar N, Garg R, Mahdi AA, Verma R, Sharma PK. 25-Hydroxy Vitamin D, Vitamin D Receptor and Toll-like Receptor 2 Polymorphisms in Spinal Tuberculosis: A Case-Control Study. Medicine (Baltimore). 2016 Apr;95(17):e3418. doi: 10.1097/MD.0000000000003418.
Ojaimi S, Skinner NA, Strauss BJ, Sundararajan V, Woolley I, Visvanathan K. Vitamin D deficiency impacts on expression of toll-like receptor-2 and cytokine profile: a pilot study. J Transl Med. 2013 Jul 22;11:176. doi: 10.1186/1479-5876-11-176.
Yu, Fang & Cailiang, Shen. (2019). Effect of vitamin D combined with anti-tuberculosis drugs on serum IL-1β, IFN-γ and TH17 cell-associated cytokines for the management of spinal tuberculosis. Tropical Journal of Pharmaceutical Research. 18. 1141-1147. 10.4314/tjpr.v18i5.32.
Other Identifiers
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0204221709
Identifier Type: -
Identifier Source: org_study_id
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