Immunity, Tuberculosis, Vitamin D
Conditions
Keywords
tuberculosis, vitamin D, immunity
Brief summary
The goal of this study is to understand the effects of vitamin D supplementation on immunological outcomes among patients with tuberculosis.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTVitamin D (600 IU)
Daily oral dose for 12 months
DIETARY_SUPPLEMENTVitamin D (2000 IU)
Daily oral dose for 12 months
DIETARY_SUPPLEMENTVitamin D (4000 IU)
Daily oral dose for 12 months
OTHERPlacebo
Daily oral dose for 12 months
Sponsors
Arogyavaram Medical Centre
Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune function | One year | Immune responses will be assessed by the superoxide bursts and proteolytic capacities of macrophages and monocytes. Activity indexes will be assessed by comparing mean substrate and calibration fluorescence. |
| Cell-mediated immunological markers | One year | T cells |
| Vitamin D status | One year | Serum 25(OH)D concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TB treatment outcomes | One year | TB treatment success and relapse |
| HIV disease progression | One year | WHO HIV disease stages |
Countries
India, United States
Contacts
Primary ContactSaurabh Mehta, MBBS, ScD
Backup ContactElaine Yu, MPH
Outcome results
None listed