Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren

Latent Tuberculosis Clinical Trial

— ViDiKids  

Official title:

Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880982
• Other study ID #: 9408
• Status: Completed
• Phase: Phase 3
• Start date: March 14, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2022
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1743
• Est. completion date: June 30, 2022
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Intervention

Dietary Supplement:
• Cholecalciferol
Weekly oral softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3)

Other:
• Placebo
Weekly oral placebo softgel capsule

Locations

Country	Name	City	State
South Africa	Desmond Tutu HIV Foundation	Cape Town	Western Cape

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition of latent tuberculosis infection		3 years
Secondary	Incidence of active tuberculosis (TB)		3 years
Secondary	Incidence of acute respiratory infection		3 years
Secondary	Incidence of acute asthma exacerbation		3 years
Secondary	Incidence and control of asthma, allergic rhinitis and atopic dermatitis		3 years
Secondary	Incidence of bone fracture		3 years
Secondary	Anthropometric outcomes (weight, height, body mass index, waist circumference)		3 years
Secondary	Mathematics examination result		3 years
Secondary	Stage of pubertal development, self-assessed using the Tanner scale		3 years
Secondary	Bone mineral content, lumbar spine and whole body minus head		3 years
Secondary	Body composition including fat mass and fat-free soft tissue mass		3 years
Secondary	Muscle strength (grip strength, elastic leg strength)		3 years
Secondary	Estimated maximal oxygen uptake, derived from 20 meter shuttle test performance		3 years
Secondary	Bronchial hyper-responsiveness to exercise		3 years
Secondary	Sensitisation to aeroallergens		3 years
Secondary	Concentrations of antigen-stimulated inflammatory mediators		3 years
Secondary	Vitamin D status, parathyroid hormone and circulating markers of bone formation and modelling		3 years
Secondary	Attention Deficit Hyperactivity Disorder Rating Scale-IV score		3 years
Secondary	Cost-effectiveness of vitamin D3 for prevention of LTBI and active TB		3 years
Secondary	Incidence of potential adverse reactions to vitamin D3		3 years
Secondary	Incidence of serious adverse events due to any cause		3 years
Secondary	Incidence of fatal or life-threatening serious adverse events due to any cause		3 years
Secondary	Proportion of participants sero-positive for SARS-CoV-2 at follow-up		3 years
Secondary	Proportion of participants sero-positive for seasonal coronaviruses HKU1, 229E, OC43 and NL63 at follow-up		3 years
Secondary	Proportion of participants sero-positive for influenza A and B at follow-up		3 years