Role of Vitamin D in Innate Immunity to Tuberculosis

Harvard School of Public Health (HSPH)120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

120

Conditions

Vitamin D Deficiency Tuberculosis

Interventions

Vitamin DDIETARY_SUPPLEMENT

Daily dose of 800IU of vitamin D

PlaceboDIETARY_SUPPLEMENT

Identically appearing capsules

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Serum vitamin D levels

Time frame: 6 months

Tuberculin Skin Test conversion

Time frame: 6 monhs

Data from ClinicalTrials.gov

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