The Effect of Vitamin D Supplementation on Toll-Like Receptor (TLR) 2, 4, and Clinical Outcomes of Spondylitis Tuberculosis
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Toll-Like Receptor 2 (TLR-2)
Study Overview
Brief Summary
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
Detailed Description
Target population:
Patients with spondylitis tuberculosis without the involvement of lung and other extrapulmonary infection
Design:
Randomized Clinical Trial with 3 arms
Primary Intervention:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants will be masked from the intervention by giving a similar vitamin D preparation in each group. Investigator, Care Provider, and Outcome Assessor are blinded from allocation and only the Allocator knows the participants assigned groups
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed as Spondylitis Tuberculosis (Clinically and Laboratory confirmed)
- •Level of Total Vitamin D <50 nmol/L at baseline
Exclusion Criteria
- •Participants with pulmonary tuberculosis or other extrapulmonary tuberculosis
- •Participants with osteoporosis, malignancy, cardiovascular disease, diabetes mellitus, and autoimmune disease
- •Participants with liver and kidney dysfunction
- •Participants who received Vitamin D prior to enrollment
Arms & Interventions
Control Group
This group will be given standardized tuberculosis drug with 400 IU of oral Vitamin D3
Intervention: 400 IU (Dietary Supplement)
Control Group
This group will be given standardized tuberculosis drug with 400 IU of oral Vitamin D3
Intervention: Fixed Drug Combination (Drug)
Moderate Dose
This group will be given standardized tuberculosis drug with 5000 IU of oral Vitamin D3
Intervention: 5000 IU (Dietary Supplement)
Moderate Dose
This group will be given standardized tuberculosis drug with 5000 IU of oral Vitamin D3
Intervention: Fixed Drug Combination (Drug)
High Dose
This group will be given standardized tuberculosis drug with 10000 IU of oral Vitamin D3
Intervention: 10000 IU (Dietary Supplement)
High Dose
This group will be given standardized tuberculosis drug with 10000 IU of oral Vitamin D3
Intervention: Fixed Drug Combination (Drug)
Outcomes
Primary Outcomes
Toll-Like Receptor 2 (TLR-2)
Time Frame: Changes of TLR-2 level from Baseline to 8 weeks
The level of TLR-2 in blood measured using ELISA
Toll-Like Receptor 4 (TLR-2)
Time Frame: Changes of TLR-4 level from Baseline to 8 weeks
The level of TLR-4 in blood measured using ELISA
The Oswestry Disability Index
Time Frame: Changes of Score from Baseline to 8 weeks
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
The Visual Analogue Scale
Time Frame: Changes of Score from Baseline to 8 weeks
This scale represent the pain according to a visual score measured using 10-likert scale. Maximum number indicates extreme/intractable pain
Secondary Outcomes
No secondary outcomes reported
Investigators
Bumi Herman
Assitant Lecturer
Hasanuddin University