Tuberculosis, Vitamin D Deficiency
Conditions
Keywords
vitamin D deficiency, tuberculin sin test, immunity, tuberculosis
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
Daily dose of 800IU of vitamin D
DIETARY_SUPPLEMENTPlacebo
Identically appearing capsules
Sponsors
Harvard School of Public Health (HSPH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum vitamin D levels | 6 months |
| Tuberculin Skin Test conversion | 6 monhs |
Outcome results
None listed