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Role of Vitamin D in Innate Immunity to Tuberculosis

NCT ID: NCT01244204

Last Updated: 2012-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vitamin D Deficiency Tuberculosis

Keywords

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vitamin D deficiency tuberculin sin test immunity tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vitamin D

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Daily dose of 800IU of vitamin D

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Identically appearing capsules

Interventions

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Vitamin D

Daily dose of 800IU of vitamin D

Intervention Type DIETARY_SUPPLEMENT

Placebo

Identically appearing capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Ganmaa Davaasambuu

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Countries

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United States

References

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Yegorov S, Bromage S, Boldbaatar N, Ganmaa D. Effects of Vitamin D Supplementation and Seasonality on Circulating Cytokines in Adolescents: Analysis of Data From a Feasibility Trial in Mongolia. Front Nutr. 2019 Oct 23;6:166. doi: 10.3389/fnut.2019.00166. eCollection 2019.

Reference Type DERIVED
PMID: 31709259 (View on PubMed)

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. doi: 10.3945/ajcn.112.034967. Epub 2012 Jul 3.

Reference Type DERIVED
PMID: 22760564 (View on PubMed)

Other Identifiers

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1K99HL089710-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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