Role of Vitamin D in Innate Immunity to Tuberculosis
Not Applicable
Completed
- Conditions
- Vitamin D DeficiencyTuberculosis
- Interventions
- Dietary Supplement: Vitamin DDietary Supplement: Placebo
- Registration Number
- NCT01244204
- Lead Sponsor
- Harvard School of Public Health (HSPH)
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Eligible subjects will be children age 12 to 15 years inclusive in public school, located in Songino-Khairhan district, who are residents of Ulaanbaatar, and whose parents have given informed consent and who accent to participate in the study.
Exclusion Criteria
- Individuals with pre-existing calcium, parathyroid conditions, or type I diabetes, sarcoidosis, or who require chronic diuretic therapy including calcium channel blockers, or who are cognitively impaired.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D Vitamin D - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Serum vitamin D levels 6 months Tuberculin Skin Test conversion 6 monhs
- Secondary Outcome Measures
Name Time Method