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
  Purpose

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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • Tuberculin Skin Test conversion [ Time Frame: 6 monhs ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Harvard School of Public Health

Additional 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: 1 K99 HL089710-01A1
Study First Received: November 15, 2010
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014