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Completed

NCT Number: NCT02880982

Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren

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.

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Key information

Conditions

Latent Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Mycobacterium Infections Tuberculosis

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Desmond Tutu HIV Foundation

Cape Town, Western Cape, 7925, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Cholecalciferol

Dietary Supplement

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

Other names: Vitamin D3

Placebo

Other

Weekly oral placebo softgel capsule

Primary outcomes

  1. Acquisition of latent tuberculosis infection

    Time frame: 3 years

Secondary outcomes

  1. Incidence of active tuberculosis (TB)

    Time frame: 3 years

  2. Incidence of acute respiratory infection

    Time frame: 3 years

  3. Incidence of acute asthma exacerbation

    Time frame: 3 years

  4. Incidence and control of asthma, allergic rhinitis and atopic dermatitis

    Time frame: 3 years

  5. Incidence of bone fracture

    Time frame: 3 years

  6. Anthropometric outcomes (weight, height, body mass index, waist circumference)

    Time frame: 3 years

  7. Mathematics examination result

    Time frame: 3 years

  8. Stage of pubertal development, self-assessed using the Tanner scale

    Time frame: 3 years

  9. Bone mineral content, lumbar spine and whole body minus head

    Time frame: 3 years

  10. Body composition including fat mass and fat-free soft tissue mass

    Time frame: 3 years

  11. Muscle strength (grip strength, elastic leg strength)

    Time frame: 3 years

  12. Estimated maximal oxygen uptake, derived from 20 meter shuttle test performance

    Time frame: 3 years

  13. Bronchial hyper-responsiveness to exercise

    Time frame: 3 years

  14. Sensitisation to aeroallergens

    Time frame: 3 years

  15. Concentrations of antigen-stimulated inflammatory mediators

    Time frame: 3 years

  16. Vitamin D status, parathyroid hormone and circulating markers of bone formation and modelling

    Time frame: 3 years

  17. Attention Deficit Hyperactivity Disorder Rating Scale-IV score

    Time frame: 3 years

  18. Cost-effectiveness of vitamin D3 for prevention of LTBI and active TB

    Time frame: 3 years

  19. Incidence of potential adverse reactions to vitamin D3

    Time frame: 3 years

  20. Incidence of serious adverse events due to any cause

    Time frame: 3 years

  21. Incidence of fatal or life-threatening serious adverse events due to any cause

    Time frame: 3 years

  22. Proportion of participants sero-positive for SARS-CoV-2 at follow-up

    Time frame: 3 years

  23. Proportion of participants sero-positive for seasonal coronaviruses HKU1, 229E, OC43 and NL63 at follow-up

    Time frame: 3 years

  24. Proportion of participants sero-positive for influenza A and B at follow-up

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • University of Cape Town

Registry information

Acronym: ViDiKids

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Aug 26, 2016
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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