Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren
- Conditions
- Latent Tuberculosis
- Interventions
- Dietary Supplement: CholecalciferolOther: Placebo
- Registration Number
- NCT02880982
- Lead Sponsor
- Queen Mary University of London
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1743
- Pupil enrolled in Grades 1-4 of participating primary schools
- Age 6-11 years at enrolment
- Pupil gives written informed assent to participate in main trial
- Pupil's parent / legal guardian gives informed consent for pupil to participate in main trial
- Age ≤5 years or ≥12 years at enrolment
- Previous positive Interferon-Gamma Release Assay (IGRA) or Mantoux test
- Previous treatment for LTBI or active TB
- Clinical signs of rickets
- History of myalgia on walking
- Inability to rise unaided from squatting position
- Taking supplemental vitamin D at a dose >400 IU daily or equivalent in the previous month
- Diagnosis of any chronic illness other than asthma
- Suspected HIV infection in child with parent or legal guardian declining to have child HIV-tested
- Use of any regular medication other than asthma medication
- Plans to move away from study area within 3 years of enrolment
- Unable to swallow one placebo softgel with ease
- Positive Quantiferon-TB Gold Plus test at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Cholecalciferol Softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3) to be taken orally once per week for 3 years Placebo Placebo Softgel capsule of identical taste and appearance to active comparator, but containing no cholecalciferol, to be taken orally once per week for 3 years
- Primary Outcome Measures
Name Time Method Acquisition of latent tuberculosis infection 3 years
- Secondary Outcome Measures
Name Time Method Incidence of serious adverse events due to any cause 3 years Incidence of active tuberculosis (TB) 3 years Body composition including fat mass and fat-free soft tissue mass 3 years Incidence of acute respiratory infection 3 years Mathematics examination result 3 years Stage of pubertal development, self-assessed using the Tanner scale 3 years Estimated maximal oxygen uptake, derived from 20 meter shuttle test performance 3 years Bronchial hyper-responsiveness to exercise 3 years Attention Deficit Hyperactivity Disorder Rating Scale-IV score 3 years Incidence of bone fracture 3 years Bone mineral content, lumbar spine and whole body minus head 3 years Muscle strength (grip strength, elastic leg strength) 3 years Sensitisation to aeroallergens 3 years Concentrations of antigen-stimulated inflammatory mediators 3 years Incidence of potential adverse reactions to vitamin D3 3 years Incidence of fatal or life-threatening serious adverse events due to any cause 3 years Proportion of participants sero-positive for SARS-CoV-2 at follow-up 3 years Incidence and control of asthma, allergic rhinitis and atopic dermatitis 3 years Anthropometric outcomes (weight, height, body mass index, waist circumference) 3 years Vitamin D status, parathyroid hormone and circulating markers of bone formation and modelling 3 years Cost-effectiveness of vitamin D3 for prevention of LTBI and active TB 3 years Proportion of participants sero-positive for influenza A and B at follow-up 3 years Proportion of participants sero-positive for seasonal coronaviruses HKU1, 229E, OC43 and NL63 at follow-up 3 years Incidence of acute asthma exacerbation 3 years
Trial Locations
- Locations (1)
Desmond Tutu HIV Foundation
🇿🇦Cape Town, Western Cape, South Africa