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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02880982
Recruitment Status : Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Queen Mary University of London

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

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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

Resource links provided by the National Library of Medicine


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




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 ]


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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

Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Keren Middelkoop, MPH, PhD University of Cape Town
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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: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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