NCT02880982已完成3 期
Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,743
- 试验地点
- 2
- 主要终点
- Acquisition of latent tuberculosis infection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Acquisition of latent tuberculosis infection
时间窗: 3 years
次要结局
- Incidence of serious adverse events due to any cause(3 years)
- Incidence of active tuberculosis (TB)(3 years)
- Body composition including fat mass and fat-free soft tissue mass(3 years)
- Incidence of acute respiratory infection(3 years)
- Mathematics examination result(3 years)
- Stage of pubertal development, self-assessed using the Tanner scale(3 years)
- Estimated maximal oxygen uptake, derived from 20 meter shuttle test performance(3 years)
- Bronchial hyper-responsiveness to exercise(3 years)
- Attention Deficit Hyperactivity Disorder Rating Scale-IV score(3 years)
- Incidence of bone fracture(3 years)
- Bone mineral content, lumbar spine and whole body minus head(3 years)
- Muscle strength (grip strength, elastic leg strength)(3 years)
- Sensitisation to aeroallergens(3 years)
- Concentrations of antigen-stimulated inflammatory mediators(3 years)
- Incidence of potential adverse reactions to vitamin D3(3 years)
- Incidence of fatal or life-threatening serious adverse events due to any cause(3 years)
- Proportion of participants sero-positive for SARS-CoV-2 at follow-up(3 years)
- Incidence of acute asthma exacerbation(3 years)
- Incidence and control of asthma, allergic rhinitis and atopic dermatitis(3 years)
- Anthropometric outcomes (weight, height, body mass index, waist circumference)(3 years)
- Vitamin D status, parathyroid hormone and circulating markers of bone formation and modelling(3 years)
- Cost-effectiveness of vitamin D3 for prevention of LTBI and active TB(3 years)
- Proportion of participants sero-positive for influenza A and B at follow-up(3 years)
- Proportion of participants sero-positive for seasonal coronaviruses HKU1, 229E, OC43 and NL63 at follow-up(3 years)
研究者
研究点 (2)
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