Back to resultsTrial of Vitamin D Supplementation in Cape Town Primary Schoolchildren (ViDiKids)
Primary Purpose
Latent Tuberculosis
Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Latent Tuberculosis
Eligibility Criteria
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
Sites / Locations
- Desmond Tutu HIV Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention
Placebo
Arm Description
Softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3) to be taken orally once per week for 3 years
Softgel capsule of identical taste and appearance to active comparator, but containing no cholecalciferol, to be taken orally once per week for 3 years
Outcomes
Primary Outcome Measures
Acquisition of latent tuberculosis infection
Secondary Outcome Measures
Incidence of active tuberculosis (TB)
Incidence of acute respiratory infection
Incidence of acute asthma exacerbation
Incidence and control of asthma, allergic rhinitis and atopic dermatitis
Incidence of bone fracture
Anthropometric outcomes (weight, height, body mass index, waist circumference)
Mathematics examination result
Stage of pubertal development, self-assessed using the Tanner scale
Bone mineral content, lumbar spine and whole body minus head
Body composition including fat mass and fat-free soft tissue mass
Muscle strength (grip strength, elastic leg strength)
Estimated maximal oxygen uptake, derived from 20 meter shuttle test performance
Bronchial hyper-responsiveness to exercise
Sensitisation to aeroallergens
Concentrations of antigen-stimulated inflammatory mediators
Vitamin D status, parathyroid hormone and circulating markers of bone formation and modelling
Attention Deficit Hyperactivity Disorder Rating Scale-IV score
Cost-effectiveness of vitamin D3 for prevention of LTBI and active TB
Incidence of potential adverse reactions to vitamin D3
Incidence of serious adverse events due to any cause
Incidence of fatal or life-threatening serious adverse events due to any cause
Proportion of participants sero-positive for SARS-CoV-2 at follow-up
Proportion of participants sero-positive for seasonal coronaviruses HKU1, 229E, OC43 and NL63 at follow-up
Proportion of participants sero-positive for influenza A and B at follow-up
Full Information
NCT ID
NCT02880982
First Posted
July 18, 2016
Last Updated
September 7, 2022
Sponsor
Queen Mary University of London
Collaborators
University of Cape Town
1. Study Identification
Unique Protocol Identification Number
NCT02880982
Brief Title
Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren
Acronym
ViDiKids
Official Title
Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 14, 2017 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London
Collaborators
University of Cape Town
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1743 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3) to be taken orally once per week for 3 years
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Softgel capsule of identical taste and appearance to active comparator, but containing no cholecalciferol, to be taken orally once per week for 3 years
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D3
Intervention Description
Weekly oral softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Weekly oral placebo softgel capsule
Primary Outcome Measure Information:
Title
Acquisition of latent tuberculosis infection
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Incidence of active tuberculosis (TB)
Time Frame
3 years
Title
Incidence of acute respiratory infection
Time Frame
3 years
Title
Incidence of acute asthma exacerbation
Time Frame
3 years
Title
Incidence and control of asthma, allergic rhinitis and atopic dermatitis
Time Frame
3 years
Title
Incidence of bone fracture
Time Frame
3 years
Title
Anthropometric outcomes (weight, height, body mass index, waist circumference)
Time Frame
3 years
Title
Mathematics examination result
Time Frame
3 years
Title
Stage of pubertal development, self-assessed using the Tanner scale
Time Frame
3 years
Title
Bone mineral content, lumbar spine and whole body minus head
Time Frame
3 years
Title
Body composition including fat mass and fat-free soft tissue mass
Time Frame
3 years
Title
Muscle strength (grip strength, elastic leg strength)
Time Frame
3 years
Title
Estimated maximal oxygen uptake, derived from 20 meter shuttle test performance
Time Frame
3 years
Title
Bronchial hyper-responsiveness to exercise
Time Frame
3 years
Title
Sensitisation to aeroallergens
Time Frame
3 years
Title
Concentrations of antigen-stimulated inflammatory mediators
Time Frame
3 years
Title
Vitamin D status, parathyroid hormone and circulating markers of bone formation and modelling
Time Frame
3 years
Title
Attention Deficit Hyperactivity Disorder Rating Scale-IV score
Time Frame
3 years
Title
Cost-effectiveness of vitamin D3 for prevention of LTBI and active TB
Time Frame
3 years
Title
Incidence of potential adverse reactions to vitamin D3
Time Frame
3 years
Title
Incidence of serious adverse events due to any cause
Time Frame
3 years
Title
Incidence of fatal or life-threatening serious adverse events due to any cause
Time Frame
3 years
Title
Proportion of participants sero-positive for SARS-CoV-2 at follow-up
Time Frame
3 years
Title
Proportion of participants sero-positive for seasonal coronaviruses HKU1, 229E, OC43 and NL63 at follow-up
Time Frame
3 years
Title
Proportion of participants sero-positive for influenza A and B at follow-up
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keren Middelkoop, MPH, PhD
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
Facility Information:
Facility Name
Desmond Tutu HIV Foundation
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren
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