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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.
ClinicalTrials.gov Identifier: NCT01244204
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Vitamin D Deficiency Tuberculosis Dietary Supplement: Vitamin D Dietary Supplement: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : November 2009
Primary Completion Date : May 2010
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vitamin D Dietary Supplement: Vitamin D
Daily dose of 800IU of vitamin D
Placebo Comparator: Placebo Dietary Supplement: Placebo
Identically appearing capsules


Outcome Measures

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

Eligibility Criteria

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
Criteria

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.
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 Posted: November 19, 2010    Key Record Dates
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
immunity
tuberculosis

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