MedTrace Logo

Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren

NCT02880982 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1743

Last updated 2022-09-08

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Cholecalciferol

Weekly oral softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3)

OTHER

Placebo

Weekly oral placebo softgel capsule

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Keren Middelkoop, MPH, PhD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-14
Primary Completion
2021-11-17
Completion
2022-06-30

Countries

  • South Africa

Study Locations

More Related Trials

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 NCT02880982 on ClinicalTrials.gov