Vitamin D Supplementation and TB

Not Applicable

• Conditions: Immunity; Tuberculosis; Vitamin D
• Interventions: Other: Placebo; Dietary Supplement: Vitamin D (4000 IU); Dietary Supplement: Vitamin D (600 IU); Dietary Supplement: Vitamin D (2000 IU)

• Registration Number: NCT01992263
• Lead Sponsor: Cornell University

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.

Study Timeline

• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-09
• Study Start: 2021-06
• Primary Completion: 2022-09
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Vitamin D (4000 IU)	Vitamin D (4000 IU)	-
Vitamin D (600 IU)	Vitamin D (600 IU)	-
Vitamin D (2000 IU)	Vitamin D (2000 IU)	-

Primary Outcome Measures

Name	Time	Method
Cell-mediated immunological markers	One year	T cells
Vitamin D status	One year	Serum 25(OH)D concentrations
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.

Secondary Outcome Measures

Name	Time	Method
TB treatment outcomes	One year	TB treatment success and relapse
HIV disease progression	One year	WHO HIV disease stages

Trial Locations

Locations (2)

Arogyavaram Medical Centre (AMC); 🇮🇳 Madanapalle, India

Cornell University; 🇺🇸 Ithaca, New York, United States