Oral Vitamin D and Toll Like Receptor in Spondylitis Tuberculosis
Status:
Not yet recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Hasanuddin University
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins