Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren (ViDiKids)

• ClinicalTrials.gov Identifier: NCT02880982
• Recruitment Status: Active, not recruiting
• First Posted: August 26, 2016
• Last Update Posted: July 10, 2019
• Sponsor: Queen Mary University of London
• Collaborator: University of Cape Town
• Information provided by (Responsible Party): Queen Mary University of London

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.

Condition or disease	Intervention/treatment	Phase
Latent Tuberculosis	Dietary Supplement: Cholecalciferol; Other: Placebo	Phase 3

Study Design

• 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
• Estimated Primary Completion Date: March 2022
• Estimated Study Completion Date: June 2022

Arms and Interventions

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	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	Other: Placebo; Weekly oral placebo softgel capsule

Outcome Measures

Primary Outcome Measures :

1. Acquisition of latent tuberculosis infection [ Time Frame: 3 years ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

South Africa

Desmond Tutu HIV Foundation

Cape Town, Western Cape, South Africa, 7925

Sponsors and Collaborators

Queen Mary University of London

University of Cape Town

Investigators

• Principal Investigator: Keren Middelkoop, MPH, PhD; University of Cape Town

More Information

• Responsible Party: Queen Mary University of London
• ClinicalTrials.gov Identifier: NCT02880982
• Other Study ID Numbers: 9408
• First Posted: August 26, 2016
• Last Update Posted: July 10, 2019
• Last Verified: July 2019

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

Additional relevant MeSH terms:

Tuberculosis; Latent Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Vitamin D; Cholecalciferol; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents