Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren (ViDiKids)
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ClinicalTrials.gov Identifier: NCT02880982 |
Recruitment Status :
Completed
First Posted : August 26, 2016
Last Update Posted : September 8, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Latent Tuberculosis | Dietary Supplement: Cholecalciferol Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1743 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren |
Actual Study Start Date : | March 14, 2017 |
Actual Primary Completion Date : | November 17, 2021 |
Actual Study Completion Date : | June 30, 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Intervention
Softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3) to be taken orally once per week for 3 years
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Dietary Supplement: Cholecalciferol
Weekly oral softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3)
Other Name: Vitamin D3 |
Placebo Comparator: 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
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Other: Placebo
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 ]

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Ages Eligible for Study: | 6 Years to 11 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880982
South Africa | |
Desmond Tutu HIV Foundation | |
Cape Town, Western Cape, South Africa, 7925 |
Principal Investigator: | Keren Middelkoop, MPH, PhD | University of Cape Town |
Responsible Party: | Queen Mary University of London |
ClinicalTrials.gov Identifier: | NCT02880982 |
Other Study ID Numbers: |
9408 |
First Posted: | August 26, 2016 Key Record Dates |
Last Update Posted: | September 8, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tuberculosis Latent Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |
Latent Infection Vitamin D Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |