Role of Vitamin D in Innate Immunity to Tuberculosis
NCT01244204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2012-08-03
Summary
The investigators proposed a pilot study preparatory to developing a randomized trial of vitamin D for the prevention of TB infection. The specific aims are presented below:
1. To recruit subjects, obtain consent, distribute vitamin D supplements to the children in the schools, obtain blood samples and transport them to the United States.
2. To test the hypothesis that daily vitamin D supplementation will increase plasma levels of 25(OH)D, and restore TLR-induced antimicrobial activity in monocytes/macrophages tested in vitro.
Conditions
- Vitamin D Deficiency
- Tuberculosis
Interventions
- DIETARY_SUPPLEMENT
-
Vitamin D
Daily dose of 800IU of vitamin D
- DIETARY_SUPPLEMENT
-
Placebo
Identically appearing capsules
Sponsors & Collaborators
-
Harvard School of Public Health (HSPH)
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2010-05-31
- Completion
- 2011-03-31
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