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

Queen Mary University of London

Status and phase: Completed; Phase 3

Conditions: Latent Tuberculosis

Treatments: Dietary Supplement: Cholecalciferol; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02880982

9408

Details and patient eligibility

About

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.

Enrollment: 1,743 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,743 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Cholecalciferol

Placebo

Placebo Comparator group

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

Treatment:

Other: Placebo