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Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren — ViDiKids  

Latent Tuberculosis Clinical Trial

Official title:
Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren

Clinical Trial Summary

The investigators will conduct a n=5,400 Phase 3, double-blind, individually randomised placebo-controlled clinical trial of 5 years' duration in primary schools in City of Cape Town Metropolitan Municipality, Western Cape Province, Republic of South Africa. The primary objective of the trial is to determine whether a weekly oral dose of 0.25 mg (10,000 IU) vitamin D3, administered for three years, reduces risk of acquisition of latent tuberculosis infection (LTBI) in Cape Town primary schoolchildren. Statistical analysis will be performed on an intention-to-treat basis to compare acquisition of LTBI in intervention vs. control arms during three-year follow-up. The primary analysis will be logistic regression with presence/absence of LTBI at follow-up as the outcome, adjusted for a random effect of school of attendance.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02880982
Study type Interventional
Source Queen Mary University of London
Contact
Status Completed
Phase Phase 3
Start date March 14, 2017
Completion date June 30, 2022
View Details
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