NCT01992263

Vitamin D Supplementation and TB

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis
• Vitamin D
• Immunity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-09-01
• Completion: 2023-02-01
• First posted: 2013-11-25
• Last updated: 2020-09-09

Locations

2 sites across 2 countries: United States, India