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Role of Vitamin D in Innate Immunity to Tuberculosis

Primary Purpose

Vitamin D Deficiency, Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring vitamin D deficiency, tuberculin sin test, immunity, tuberculosis

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vitamin D

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Serum vitamin D levels
    Tuberculin Skin Test conversion

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2010
    Last Updated
    August 1, 2012
    Sponsor
    Harvard School of Public Health (HSPH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01244204
    Brief Title
    Role of Vitamin D in Innate Immunity to Tuberculosis
    Official Title
    Vitamin D Supplementations as Adjunct to Anti-tuberculosis Drugs in Mongolia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    May 2010 (Actual)
    Study Completion Date
    March 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Harvard School of Public Health (HSPH)

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency, Tuberculosis
    Keywords
    vitamin D deficiency, tuberculin sin test, immunity, tuberculosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vitamin D
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin D
    Intervention Description
    Daily dose of 800IU of vitamin D
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Identically appearing capsules
    Primary Outcome Measure Information:
    Title
    Serum vitamin D levels
    Time Frame
    6 months
    Title
    Tuberculin Skin Test conversion
    Time Frame
    6 monhs

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31709259
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    22760564
    Citation
    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.
    Results Reference
    derived

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    Role of Vitamin D in Innate Immunity to Tuberculosis

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