Role of Vitamin D in Innate Immunity to Tuberculosis

NCT01244204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-08-03

No results posted yet for this study

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

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01244204 on ClinicalTrials.gov