Trial | NCT01992263  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    200
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.
Study Started
Jun 30
2021
Anticipated
Primary Completion
Sep 30
2022
Anticipated
Study Completion
Feb 28
2023
Anticipated
Last Update
Sep 09
2020

Dietary Supplement Vitamin D (600 IU)

Daily oral dose for 12 months

Dietary Supplement Vitamin D (2000 IU)

Daily oral dose for 12 months

Dietary Supplement Vitamin D (4000 IU)

Daily oral dose for 12 months

Other Placebo

Daily oral dose for 12 months

Vitamin D (600 IU) Experimental

Vitamin D (2000 IU) Experimental

Vitamin D (4000 IU) Experimental

Placebo Placebo Comparator

Criteria 

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)
No Results Posted