Role of Vitamin D in Innate Immunity to Tuberculosis

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.

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Key information

Conditions

Vitamin D Deficiency Actinomycetales Infections Avitaminosis Bacterial Infections Bacterial Infections and Mycoses Deficiency Diseases Gram-Positive Bacterial Infections Infections Malnutrition Mycobacterium Infections Nutrition Disorders Nutritional and Metabolic Diseases Tuberculosis

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Dietary Supplement

Daily dose of 800IU of vitamin D

Placebo

Dietary Supplement

Identically appearing capsules

Primary outcomes

Serum vitamin D levels

Time frame: 6 months
Tuberculin Skin Test conversion

Time frame: 6 monhs

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Registry information

Official study title

Vitamin D Supplementations as Adjunct to Anti-tuberculosis Drugs in Mongolia

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Nov 19, 2010
Registry last updated: Aug 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed