Vitamin D Supplementation and TB

Status:Not yet recruiting
Conditions:Food Studies, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pharmacology / Toxicology
Age Range:18 - 60
Start Date:June 2019
End Date:February 2020
Contact:Saurabh Mehta, MBBS, ScD

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A Trial of Vitamin D Supplementation Among Tuberculosis Patients in South India

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

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.

Inclusion Criteria:

- Active TB diagnosis by GeneXpert

- HIV infection status (according to AMC HIV clinic medical records of enzyme-linked
immunosorbent assay [ELISA] results)

Exclusion Criteria:

- Children (<18 years of age)

- 60 years of age

- Pregnant at baseline

- Other severe complications or illnesses requiring hospitalization

- Received TB treatment for greater than 4 weeks in the past 5 years

- Refused to participate

- Residing in a geographic location > 1 hour from AMC (by public transit)
We found this trial at
Ithaca, New York 14853
Principal Investigator: Saurabh Mehta, MBBS, ScD
Phone: 714-478-8599
Ithaca, NY
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Madanapalle, 517325
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