NCT05376189

Oral Vitamin D and Toll Like Receptor in Spondylitis Tuberculosis

Status unknown Phase 2, PHASE3 Last updated 17 May 2022

What this trial tests

Phase 2, PHASE3 trial testing 400 IU in Spondylitis in 37 participants. Status unknown.

Timeline

1 July 2022

Primary endpoint
30 December 2022

1 February 2023

Quick facts

Lead sponsor	Hasanuddin University
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	37
Start date	1 July 2022
Primary completion	30 December 2022
Estimated completion	1 February 2023
Sites	1 location across Indonesia

Drugs / interventions tested

• 400 IU
• 5000 IU
• 10000 IU
• Fixed Drug Combination — full drug profile →

Conditions studied

• Spondylitis — all drugs for Spondylitis →
• Tuberculosis — all drugs for Tuberculosis →

Sponsor

Hasanuddin University

Who can join

Adults 19 to 50, any sex, with Spondylitis or Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The advances in adjuvant therapy for tuberculosis with immunoregulatory compounds.
   Mi J, Wu X, Liang J. · · 2024 · cited 5× · PMID 38966394 · DOI 10.3389/fmicb.2024.1380848
2. Repurposed Drugs and Plant-Derived Natural Products as Potential Host-Directed Therapeutic Candidates for Tuberculosis.
   Raqib R, Sarker P. · · 2024 · cited 4× · PMID 39766204 · DOI 10.3390/biom14121497
3. Randomized controlled trial of vitamin d supplementation on toll-like receptor-2 (tlr-2) and toll-like receptor-4 (tlr-4) in tuberculosis spondylitis patients.
   Arifin J, Massi MN, Biakto KT, Bukhari A, et al · · 2023 · cited 3× · PMID 38129893 · DOI 10.1186/s13018-023-04445-6
4. Impact of Vitamin D Suplementation in Clinical Outcome at Tuberculosis Spondylitis : Randomized Controlled Trial
   Arifin J, Massi MN, Biakto KT, Bukhari A, et al · · 2024 · DOI 10.21203/rs.3.rs-4247144/v1