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Role of Vitamin D in Innate Immunity to Tuberculosis

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

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
Dietary Supplement: Vitamin D
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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 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


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.
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No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ganmaa Davaasambuu, Assistant Professor of Medicine, Harvard School of Public Health Identifier: NCT01244204     History of Changes
Other Study ID Numbers: 1K99HL089710-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: November 15, 2010
Last Updated: August 1, 2012

Keywords provided by 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 processed this record on April 21, 2017