Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren

NCT02880982 | Completed Phase 3 DMC

• 1 other identifier: 9408
• Study Type: interventional
• Target: 1,743
• Locations: 1 country
• Sites: 1

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.

Conditions

Latent Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Acquisition of latent tuberculosis infection

  3 years

Secondary Outcomes (24)

• Incidence of active tuberculosis (TB)

  3 years

• Incidence of acute respiratory infection

  3 years

• Incidence of acute asthma exacerbation

  3 years

• Incidence and control of asthma, allergic rhinitis and atopic dermatitis

  3 years

• Incidence of bone fracture

  3 years

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3) to be taken orally once per week for 3 years

Dietary Supplement: Cholecalciferol

Placebo

PLACEBO COMPARATOR

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

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

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

Also known as: Vitamin D3

Intervention

Placebo OTHER

Weekly oral placebo softgel capsule

Placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead
• University of Cape Town: collaborator

Study Sites (1)

Desmond Tutu HIV Foundation

Cape Town, Western Cape, 7925, South Africa

Location

Related Publications (1)

• 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.

  PMID: 38599800 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Keren Middelkoop, MPH, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: August 26, 2016
• Study Start: March 14, 2017
• Primary Completion: November 17, 2021
• Study Completion: June 30, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-01

Locations

ZA (1)