Effect of Vitamin D as Adjunctive Therapy in Patients With Pulmonary Evolution Tuberculosis — VitaminD  

Pulmonary Tuberculosis Clinical Trial

Official title: Effect of Vitamin D as Adjunctive Therapy in Patients With Pulmonary Evolution Tuberculosis in the National Institute of Respiratory Diseases

Status Recruiting

Clinical Trial Summary

Tuberculosis (TB) is the second largest infectious disease that causes death in the last 4 centuries in all the world. Observational studies found an association between vitaminD and TB, suggesting a potential therapeutic role of vitaminD supplementation in patients with active tuberculosis. The hypothesis is that the administration of vitaminD is associated with changes in the levels of cytokines in patients with tuberculosis treated with first-line drugs. The aim of this study is to evaluate the effect of vitaminD supplementation on the clinical course, the time of negative smears and cultures, and the effect on the immune response in patients with pulmonary tuberculosis (TBP).

Clinical Trial Description

We are going to include of 60 patients diagnosed with confirmed TBP with and without diabetes mellitus, by positive smear and culture for Mycobacterium tuberculosis sensitive to first-line drugs (rifampicin, isoniazid, pyrazinamide and ethambutol), which will be grouped as follows: 1) patients who receive vitamin D (VD) (n = 30) and 2) patients who not receive vitamin D (NVD) (n = 30) in addition to drug treatment of tuberculosis drug frontline. Blood samples must be taken each month until the end of treatment.The VD group of participants will receive treatment with a daily dose of Vitamin D 200 International Units (IU) during the first two months of treatment. All Patients who participate must give their written consent.

First, we are going to separate the peripheral blood mononuclear cells with Ficoll reagent. Then, for the determination of intracellular cytokines in basal conditions and after the antigenic stimulation with M.tuberculosis, the flow cytometric technique is going to be used and the results will be analyzing in a flow cytometer. We are going to infected cells with M. tuberculosis strain at a multiplicity of infection (MOI) of 1 and 10, in order to determinate phagocytosis and bactericidal activity of peripheral whole blood of patients, using Colony Forming Units (CFU) and staining. Extraction of RNA will be performed according to the kit supplier. The amplification reaction is going to perform with Applied Biosystems and Sybr Green Master Mix. We are going to use the unpaired Student t test, for the normal distribution parameters. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

• NCT number: NCT02464683
• Study type: Interventional
• Source: Instituto Nacional de Enfermedades Respiratorias
• Contact: MARTHA TORRES ROJAS, PhD
• Phone: 54871700
• Email: marthatorres98@yahoo.com
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2014
• Completion date: December 2016