Role of Vitamin D in Innate Immunity to Tuberculosis
Vitamin D Supplementations as Adjunct to Anti-tuberculosis Drugs in Mongolia
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 15, 2010
CompletedFirst Posted
Study publicly available on registry
November 19, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedAugust 3, 2012
August 1, 2012
6 months
November 15, 2010
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Serum vitamin D levels
6 months
Tuberculin Skin Test conversion
6 monhs
Study Arms (2)
Vitamin D
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Yegorov S, Bromage S, Boldbaatar N, Ganmaa D. Effects of Vitamin D Supplementation and Seasonality on Circulating Cytokines in Adolescents: Analysis of Data From a Feasibility Trial in Mongolia. Front Nutr. 2019 Oct 23;6:166. doi: 10.3389/fnut.2019.00166. eCollection 2019.
PMID: 31709259DERIVEDGanmaa D, Giovannucci E, Bloom BR, Fawzi W, Burr W, Batbaatar D, Sumberzul N, Holick MF, Willett WC. Vitamin D, tuberculin skin test conversion, and latent tuberculosis in Mongolian school-age children: a randomized, double-blind, placebo-controlled feasibility trial. Am J Clin Nutr. 2012 Aug;96(2):391-6. doi: 10.3945/ajcn.112.034967. Epub 2012 Jul 3.
PMID: 22760564DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
November 15, 2010
First Posted
November 19, 2010
Study Start
November 1, 2009
Primary Completion
May 1, 2010
Study Completion
March 1, 2011
Last Updated
August 3, 2012
Record last verified: 2012-08