Role of Vitamin D in Innate Immunity to Tuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01244204
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : August 3, 2012
Information provided by (Responsible Party):
Ganmaa Davaasambuu, Harvard School of Public Health

November 15, 2010
November 19, 2010
August 3, 2012
November 2009
May 2010   (Final data collection date for primary outcome measure)
  • Serum vitamin D levels [ Time Frame: 6 months ]
  • Tuberculin Skin Test conversion [ Time Frame: 6 monhs ]
Same as current
Complete list of historical versions of study NCT01244204 on Archive Site
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Role of Vitamin D in Innate Immunity to Tuberculosis
Vitamin D Supplementations as Adjunct to Anti-tuberculosis Drugs in Mongolia

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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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
  • Vitamin D Deficiency
  • Tuberculosis
  • Dietary Supplement: Vitamin D
    Daily dose of 800IU of vitamin D
  • Dietary Supplement: Placebo
    Identically appearing capsules
  • Experimental: Vitamin D
    Intervention: Dietary Supplement: Vitamin D
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Ganmaa 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2011
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
10 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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United States
1K99HL089710-01A1( U.S. NIH Grant/Contract )
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Ganmaa Davaasambuu, Harvard School of Public Health
Harvard School of Public Health
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Not Provided
Harvard School of Public Health
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP