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Vitamin D Supplementation in TB Prevention

NCT02276755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8851

Last updated 2020-07-16

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether vitamin D supplementation reduces risk of acquiring latent tuberculosis infection (LTBI) in school age children in Mongolia. The investigators hypothesize that (1) vitamin D supplementation will reduce risk of acquisition of LTBI, (2) vitamin D supplementation will safely reduce risk of developing active TB and improve other secondary efficacy outcomes, and (3) children with the lowest vitamin D status at baseline will gain most from the intervention.

Conditions

  • Latent Tuberculosis

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol (vitamin D3)

14000 IU vitamin D3 weekly Experimental group will receive vitamin D supplement (Tishcon, USA).

OTHER

Placebo

Placebo group will receive placebo (Tishcon, USA) weekly.

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Davaasambuu Ganmaa, MD PhD · Harvard School of Public Health (HSPH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-06-30
Completion
2020-06-30

Countries

  • Mongolia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02276755 on ClinicalTrials.gov