A Phase 2/3 interventional study of 400 IU and 5000 IU in Spondylitis and Tuberculosis, sponsored by Hasanuddin University. Status unknown at 1 site in Indonesia. Open to participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by Hasanuddin University · Phase 2/3, Interventional, and Treatment
Background :
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
Target population:
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:
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
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 :
Hence total sample should be 37 participants
Proposed Statistical Analysis
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's planned enrollment of 37 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Hasanuddin University is the lead sponsor of 65 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will be given standardized tuberculosis drug with 400 IU of oral Vitamin D3
Dietary Supplement: 400 IU · Drug: Fixed Drug Combination
This group will be given standardized tuberculosis drug with 5000 IU of oral Vitamin D3
Dietary Supplement: 5000 IU · Drug: Fixed Drug Combination
This group will be given standardized tuberculosis drug with 10000 IU of oral Vitamin D3
Dietary Supplement: 10000 IU · Drug: Fixed Drug Combination
An Oral Vitamin D3 400 IU will be given once daily for a total of 8 weeks
Also known as: Low Dose Vitamin D3
An Oral Vitamin D3 5000 IU will be given once daily for a total of 8 weeks
Also known as: Moderate Dose Vitamin D3
An Oral Vitamin D3 10000 IU will be given once daily for a total of 8 weeks
Also known as: High Dose Vitamin D3
Standard Tuberculosis Regimen in a form of Fixed Drug Combination (FDC) given for Spondylitis Tuberculosis.
Also known as: Tuberculosis Regimen
The Oswestry Disability Index
This questionnaire assess the impact of back pain to the daily life. This questionnaire contains 10 6-likert scale questions with the score ranging from 0-5 for each questions. The total score ranging from 0-50. The index is calculated as raw score per total score and presented as percentage. Below is the classification and interpretation of the score: 0% -20%: Minimal disability 21%-40%: Moderate Disability 41%-60%: Severe Disability 61%-80%: Crippling back pain 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms
Time frame: Changes of Score from Baseline to 8 weeks
The Visual Analogue Scale
This scale represent the pain according to a visual score measured using 10-likert scale. Maximum number indicates extreme/intractable pain
Time frame: Changes of Score from Baseline to 8 weeks
Toll-Like Receptor 2 (TLR-2)
The level of TLR-2 in blood measured using ELISA
Time frame: Changes of TLR-2 level from Baseline to 8 weeks
Toll-Like Receptor 4 (TLR-2)
The level of TLR-4 in blood measured using ELISA
Time frame: Changes of TLR-4 level from Baseline to 8 weeks
Plan to share: No — As the data is confidential. The data sharing will be granted by investigator upon request
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Hasanuddin University