NCT02880982

Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,743 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Latent Tuberculosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholecalciferol	Weekly oral softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3)
OTHER	Placebo	Weekly oral placebo softgel capsule

Timeline

• Start date: 2017-03-14
• Primary completion: 2021-11-17
• Completion: 2022-06-30
• First posted: 2016-08-26
• Last updated: 2022-09-08

Locations

1 site across 1 country: South Africa