Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1743 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-14

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Latent Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

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

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Weekly oral placebo softgel capsule

Interventions

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Cholecalciferol

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Weekly oral placebo softgel capsule

Intervention Type OTHER

Other Intervention Names

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Vitamin D3

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes