Role of Vitamin D in Innate Immunity to Tuberculosis

Tuberculosis Clinical Trial

Official title:

Vitamin D Supplementations as Adjunct to Anti-tuberculosis Drugs in Mongolia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244204
• Other study ID #: 1K99HL089710-01A1
• Status: Completed
• Phase: N/A
• First received: November 15, 2010
• Last updated: August 1, 2012
• Start date: November 2009
• Est. completion date: March 2011

Study information

• Verified date: August 2012
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tuberculosis
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D
Daily dose of 800IU of vitamin D
• Placebo
Identically appearing capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Harvard School of Public Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum vitamin D levels		6 months	No
Primary	Tuberculin Skin Test conversion		6 monhs	No