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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 15, 2010
Last Updated Date	August 1, 2012
Start Date ^ICMJE	November 2009
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 18, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01244204 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Role of Vitamin D in Innate Immunity to Tuberculosis
Official Title ^ICMJE	Vitamin D Supplementations as Adjunct to Anti-tuberculosis Drugs in Mongolia
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: 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. 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Vitamin D Deficiency Tuberculosis
Intervention ^ICMJE	Dietary Supplement: Vitamin D Daily dose of 800IU of vitamin D Dietary Supplement: Placebo Identically appearing capsules
Study Arm (s)	Experimental: Vitamin D Intervention: Dietary Supplement: Vitamin D Placebo Comparator: Placebo Intervention: Dietary Supplement: Placebo
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	120
Completion Date	March 2011
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	10 Years to 18 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01244204
Other Study ID Numbers ^ICMJE	1 K99 HL089710-01A1
Has Data Monitoring Committee	No
Responsible Party	Ganmaa Davaasambuu, Harvard School of Public Health
Study Sponsor ^ICMJE	Harvard School of Public Health
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Harvard School of Public Health
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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