Role of Vitamin D in Innate Immunity to Tuberculosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ganmaa Davaasambuu, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01244204
First received: November 15, 2010
Last updated: August 1, 2012
Last verified: August 2012

November 15, 2010
August 1, 2012
November 2009
May 2010   (final data collection date for primary outcome measure)
  • Serum vitamin D levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Tuberculin Skin Test conversion [ Time Frame: 6 monhs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01244204 on ClinicalTrials.gov 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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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. Epub 2012 Jul 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
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.
Both
10 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01244204
1 K99 HL089710-01A1
No
Ganmaa Davaasambuu, Harvard School of Public Health
Harvard School of Public Health
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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