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Role of Vitamin D in Innate Immunity to Tuberculosis

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 19, 2010
Last Update Posted: August 3, 2012
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.
Information provided by (Responsible Party):
Ganmaa Davaasambuu, Harvard School of Public Health

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.

Condition Intervention
Vitamin D Deficiency Tuberculosis Dietary Supplement: Vitamin D Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Vitamin D Supplementations as Adjunct to Anti-tuberculosis Drugs in Mongolia

Resource links provided by NLM:

Further study details as provided by Ganmaa Davaasambuu, Harvard School of Public Health:

Primary Outcome Measures:
  • Serum vitamin D levels [ Time Frame: 6 months ]
  • Tuberculin Skin Test conversion [ Time Frame: 6 monhs ]

Enrollment: 120
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D Dietary Supplement: Vitamin D
Daily dose of 800IU of vitamin D
Placebo Comparator: Placebo Dietary Supplement: Placebo
Identically appearing capsules


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ganmaa Davaasambuu, Assistant Professor of Medicine, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01244204     History of Changes
Other Study ID Numbers: 1K99HL089710-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 15, 2010
First Posted: November 19, 2010
Last Update Posted: August 3, 2012
Last Verified: August 2012

Keywords provided by Ganmaa Davaasambuu, Harvard School of Public Health:
vitamin D deficiency
tuberculin sin test

Additional relevant MeSH terms:
Vitamin D Deficiency
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents