Overview

Oral Vitamin D and Toll Like Receptor in Spondylitis Tuberculosis

Status:
Not yet recruiting

Trial end date:
2023-02-01

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hasanuddin University

Treatments:

Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins

Criteria

Inclusion Criteria:

1. Diagnosed as Spondylitis Tuberculosis (Clinically and Laboratory confirmed)

2. Level of Total Vitamin D <50 nmol/L at baseline

Exclusion Criteria:

1. Participants with pulmonary tuberculosis or other extrapulmonary tuberculosis

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