Role of Vitamin D in Innate Immunity to Tuberculosis

Sponsor

Harvard School of Public Health (HSPH) (Other)

Overall Status

Completed

CT.gov ID

NCT01244204

Collaborator

(none)

120

Enrollment

Arms

15.9

Duration (Months)

Study Details

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency Tuberculosis	Dietary Supplement: Vitamin D Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

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 :

Nov 1, 2009

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

Mar 1, 2011

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

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

Serum vitamin D levels [6 months]
Tuberculin Skin Test conversion [6 monhs]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

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.