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Clinical Trial Summary

The goal of this study is to understand the effects of vitamin D supplementation on immunological outcomes among patients with tuberculosis.


Clinical Trial Description

In this randomized trial, the investigators will enroll 200 adults with active pulmonary tuberculosis (TB; among whom 40 have HIV co-infections) at the time of TB diagnosis in S India. The intervention will include daily vitamin D supplementation in 3 treatment arms (600, 2000, and 4000 IU vitamin D), compared to placebo, for 12 months. The investigators' primary objectives are to assess how vitamin D supplementation affects immunity (immunological markers, immune competence) and serum vitamin D levels. Secondary outcomes include TB treatment outcomes (successful sputum smear conversion, relapse) in all patients, and human immunodeficiency virus (HIV) disease progression among a subset of patients with HIV co-infection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01992263
Study type Interventional
Source Cornell University
Contact Saurabh Mehta, MBBS, ScD
Phone 607-255-2640
Email smehta@cornell.edu
Status Not yet recruiting
Phase N/A
Start date June 2021
Completion date February 2023

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