Vitamin D Supplementation in TB Prevention

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

PHASE3

Total Enrollment

8851 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Latent Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention: 1

Dietary Supplement: Cholecalciferol (vitamin D3)

Group Type ACTIVE_COMPARATOR

Cholecalciferol (vitamin D3)

Intervention Type DIETARY_SUPPLEMENT

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

Placebo Comparator: 2

Dietary Supplement: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Cholecalciferol (vitamin D3)

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Boys or girls aged 6 to 13 years at enrolment
2. Attending participating school in Ulaanbaatar at enrolment
3. Child gives informed assent to participate in the study
4. Child's parent/legal guardian gives informed consent for child to participate in study

Exclusion Criteria

1. Chronic medical conditions
2. Presence of LTBI on screening, as evidenced by a positive QFT-G
3. Clinical signs of rickets, or diagnosis of any other condition requiring vitamin D supplementation
4. Known primary hyperparathyroidism or sarcoidosis
5. Taking immunosuppressant or cytotoxic therapy, or vitamin D supplement \> 400IU / day
6. Plans to move away from study area within 3 years of enrolment

Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes