Role of Vitamin D in Innate Immunity to Tuberculosis

President and Fellows of Harvard College

Status: Completed

Conditions: Tuberculosis; Vitamin D Deficiency

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01244204

1K99HL089710-01A1

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Treatment:

Dietary Supplement: Vitamin D

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo