Oral Vitamin D and Toll Like Receptor in Spondylitis Tuberculosis

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

Conditions

• Spondylitis
• Tuberculosis

Interventions

DIETARY_SUPPLEMENT

400 IU

An Oral Vitamin D3 400 IU will be given once daily for a total of 8 weeks

DIETARY_SUPPLEMENT

5000 IU

An Oral Vitamin D3 5000 IU will be given once daily for a total of 8 weeks

DIETARY_SUPPLEMENT

10000 IU

An Oral Vitamin D3 10000 IU will be given once daily for a total of 8 weeks

DRUG

Fixed Drug Combination

Standard Tuberculosis Regimen in a form of Fixed Drug Combination (FDC) given for Spondylitis Tuberculosis.

Sponsors & Collaborators

• Hasanuddin University

  lead OTHER

Principal Investigators

• Jainal Arifin, MD · Hasanuddin University

• Nasrum Massi, MD. Ph.D · Hasanuddin University

• Firdaus Hamid, MD. Ph.D · Hasanuddin University

• Andi Alfian Zainuddin, MD. Ph.D · Hasanuddin University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2022-12-30

Completion

2023-02-01

Countries

• Indonesia

Study Locations