A Phase 3 interventional study of Cholecalciferol and Placebo in Latent Tuberculosis, sponsored by Queen Mary University of London. Completed at 1 site in South Africa. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-08.
Sponsored by Queen Mary University of London · Phase 3, Interventional, and Prevention
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 1,743 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3) to be taken orally once per week for 3 years
Dietary Supplement: Cholecalciferol
Softgel capsule of identical taste and appearance to active comparator, but containing no cholecalciferol, to be taken orally once per week for 3 years
Other: Placebo
Weekly oral softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3)
Also known as: Vitamin D3
Weekly oral placebo softgel capsule
Acquisition of latent tuberculosis infection
Time frame: 3 years
Incidence of active tuberculosis (TB)
Time frame: 3 years
Incidence of acute respiratory infection
Time frame: 3 years
Incidence of acute asthma exacerbation
Time frame: 3 years
Incidence and control of asthma, allergic rhinitis and atopic dermatitis
Time frame: 3 years
Incidence of bone fracture
Time frame: 3 years
Anthropometric outcomes (weight, height, body mass index, waist circumference)
Time frame: 3 years
Mathematics examination result
Time frame: 3 years
Stage of pubertal development, self-assessed using the Tanner scale
Time frame: 3 years
Bone mineral content, lumbar spine and whole body minus head
Time frame: 3 years
Body composition including fat mass and fat-free soft tissue mass
Time frame: 3 years
Muscle strength (grip strength, elastic leg strength)
Time frame: 3 years
Estimated maximal oxygen uptake, derived from 20 meter shuttle test performance
Time frame: 3 years
Bronchial hyper-responsiveness to exercise
Time frame: 3 years
Sensitisation to aeroallergens
Time frame: 3 years
Concentrations of antigen-stimulated inflammatory mediators
Time frame: 3 years
Vitamin D status, parathyroid hormone and circulating markers of bone formation and modelling
Time frame: 3 years
Attention Deficit Hyperactivity Disorder Rating Scale-IV score
Time frame: 3 years
Cost-effectiveness of vitamin D3 for prevention of LTBI and active TB
Time frame: 3 years
Incidence of potential adverse reactions to vitamin D3
Time frame: 3 years
Incidence of serious adverse events due to any cause
Time frame: 3 years
Incidence of fatal or life-threatening serious adverse events due to any cause
Time frame: 3 years
Proportion of participants sero-positive for SARS-CoV-2 at follow-up
Time frame: 3 years
Proportion of participants sero-positive for seasonal coronaviruses HKU1, 229E, OC43 and NL63 at follow-up
Time frame: 3 years
Proportion of participants sero-positive for influenza A and B at follow-up
Time frame: 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Queen Mary University of London