Vitamin D Supplementation in TB Prevention

Harvard School of Public Health (HSPH)8,851 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

8,851

Conditions

Latent Tuberculosis

Interventions

Cholecalciferol (vitamin D3)DIETARY_SUPPLEMENT

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mongolian Health Initiative

Ulaanbaatar, Mongolia

Outcomes

Primary Outcomes

Acquisition of latent tuberculosis infection

The proportion of children who acquire LTBI during the 3 year period will be compared for children randomized to vitamin D3 vs. placebo using the Mantel-Haenszel risk ratio, stratified by school of attendance. The primary analysis will compare the proportion of children who are QuantiFERON-positive at the 0.35 IU/ml IFN-gamma threshold at the end of the study. Exploratory analyses will compare the proportion of children who are positive at the 4.0 IU/ml IFN-gamma threshold (denoting stable conversion) and mean / median antigen-stimulated IFN-gamma concentration analyzed as a continuous variable.

Time frame: Three years

Secondary Outcomes

Incidence of active TB disease

All participants

Time frame: Three years

Incidence of self-reported acute respiratory infection (upper, lower and both combined)

All participants

Time frame: Three years

Incidence of acute respiratory infection requiring hospitalization

All participants

Time frame: Three years

Incidence of acute respiratory infections requiring antibiotic treatment

All participants

Time frame: Three years

Number of days off school (total number and number due to acute respiratory infection)

All participants

Time frame: Three years

Incidence of acute asthma exacerbation requiring hospitalization

Sub-set of participants with asthma at baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.