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Latent TuberculosisPhase 3ViDiKidsNCT02880982

Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren

A Phase 3 study testing Cholecalciferol in people with Latent Tuberculosis, run by Queen Mary University of London at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Latent Tuberculosis
What is being tested?
Cholecalciferol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,743 participants
Where
1 siteSouth Africa
Study dates
14 Mar 2017to 30 Jun 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Desmond Tutu HIV Foundation

    Cape Town, Western Cape, 7925

Other trials in South Africa

About this study

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.

Being tested
Cholecalciferol, Placebo
Medical subject headings
Latent Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CholecalciferolDietary supplement

    Also called Vitamin D3

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

  • PlaceboOther

    Weekly oral placebo softgel capsule

Study groups in NCT02880982
Study groupRoleWhat they receive
InterventionActive comparatorSoftgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3) to be taken orally once per week for 3 years
Receives: Dietary Supplement: Cholecalciferol
PlaceboPlacebo comparatorSoftgel capsule of identical taste and appearance to active comparator, but containing no cholecalciferol, to be taken orally once per week for 3 years
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acquisition of latent tuberculosis infection

    Measured: 3 years

Secondary outcomes (24)

  1. Incidence of active tuberculosis (TB)

    Measured: 3 years

  2. Incidence of acute respiratory infection

    Measured: 3 years

  3. Incidence of acute asthma exacerbation

    Measured: 3 years

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

    Measured: 3 years

  5. Incidence of bone fracture

    Measured: 3 years

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

    Measured: 3 years

  7. Mathematics examination result

    Measured: 3 years

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

    Measured: 3 years

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

    Measured: 3 years

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

    Measured: 3 years

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

    Measured: 3 years

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

    Measured: 3 years

  13. Bronchial hyper-responsiveness to exercise

    Measured: 3 years

  14. Sensitisation to aeroallergens

    Measured: 3 years

  15. Concentrations of antigen-stimulated inflammatory mediators

    Measured: 3 years

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

    Measured: 3 years

  17. Attention Deficit Hyperactivity Disorder Rating Scale-IV score

    Measured: 3 years

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

    Measured: 3 years

  19. Incidence of potential adverse reactions to vitamin D3

    Measured: 3 years

  20. Incidence of serious adverse events due to any cause

    Measured: 3 years

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

    Measured: 3 years

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

    Measured: 3 years

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

    Measured: 3 years

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2016 (estimated)
  2. Study start14 Mar 2017
  3. Primary completion17 Nov 2021
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,743 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02880982
Sponsor's protocol ID
9408
Acronym
ViDiKids
Status last verified
Jan 2022
First submitted
18 Jul 2016
Last updated
8 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Middelkoop K, Micklesfield L, Stewart J, Walker N, Jolliffe DA, Mendham AE, Coussens AK, Nuttall J, Tang J, Fraser WD, Momand W, Cooper C, Harvey NC, Wilkinson RJ, Bekker LG, Martineau AR. Influence of vitamin D supplementation on growth, body composition, pubertal development and spirometry in South African schoolchildren: a randomised controlled trial (ViDiKids). BMJ Paediatr Open. 2024 Apr 10;8(1):e002495. doi: 10.1136/bmjpo-2024-002495.

    PubMed 38599800

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cholecalciferol in people with Latent Tuberculosis, run by Queen Mary University of London at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acquisition of latent tuberculosis infection (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02880982, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.

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