Vitamin D Supplementation and TB
Status: | Not yet recruiting |
---|---|
Conditions: | Food Studies, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases, Pharmacology / Toxicology |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 2/20/2019 |
Start Date: | June 2019 |
End Date: | February 2020 |
Contact: | Saurabh Mehta, MBBS, ScD |
Email: | smehta@cornell.edu |
Phone: | 607-255-2640 |
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.
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.
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
2
sites
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Ithaca, New York 14853
Principal Investigator: Saurabh Mehta, MBBS, ScD
Phone: 714-478-8599
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