Vitamin D in TB Prevention in School Age Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8,851
- 试验地点
- 1
- 主要终点
- Acquisition of latent tuberculosis infection
研究概览
简要总结
The goal of this clinical trial is to determine whether vitamin D supplementation reduces risk of acquiring latent tuberculosis infection (LTBI) in school age children in Mongolia. The investigators hypothesize that (1) vitamin D supplementation will reduce risk of acquisition of LTBI, (2) vitamin D supplementation will safely reduce risk of developing active TB and improve other secondary efficacy outcomes, and (3) children with the lowest vitamin D status at baseline will gain most from the intervention.
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 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Boys or girls aged 6 to 13 years at enrolment
- •Attending participating school in Ulaanbaatar at enrolment
- •Child gives informed assent to participate in the study
- •Child's parent/legal guardian gives informed consent for child to participate in study
排除标准
- •Chronic medical conditions
- •Presence of LTBI on screening, as evidenced by a positive QFT-G
- •Clinical signs of rickets, or diagnosis of any other condition requiring vitamin D supplementation
- •Known primary hyperparathyroidism or sarcoidosis
- •Taking immunosuppressant or cytotoxic therapy, or vitamin D supplement > 400IU / day
- •Plans to move away from study area within 3 years of enrolment
结局指标
主要结局
Acquisition of latent tuberculosis infection
时间窗: Three years
The proportion of children who acquire LTBI during the 3 year period will be compared for children randomized to vitamin D3 vs. placebo using the Mantel-Haenszel risk ratio, stratified by school of attendance. The primary analysis will compare the proportion of children who are QuantiFERON-positive at the 0.35 IU/ml IFN-gamma threshold at the end of the study. Exploratory analyses will compare the proportion of children who are positive at the 4.0 IU/ml IFN-gamma threshold (denoting stable conversion) and mean / median antigen-stimulated IFN-gamma concentration analyzed as a continuous variable.
次要结局
- Incidence of active TB disease(Three years)
- Number of days off school (total number and number due to acute respiratory infection)(Three years)
- Incidence of acute respiratory infection requiring hospitalization(Three years)
- Incidence of acute asthma exacerbation requiring hospitalization(Three years)
- Incidence of new asthma, allergic rhinitis and atopic dermatitis(Three years)
- Muscle strength: grip strength and long jump distance from standing(Three years)
- Exam performance(Three years)
- Self-reported pubertal development(Three years)
- Urinary metabolome profile(Three years)
- Gut microbiome profile(Three years)
- Incidence of acute respiratory infections requiring antibiotic treatment(Three years)
- Anthropometric outcomes (z-scores for height-for-age, weight-for-age, weight-for-height, body mass index-for-age, and waist circumference and waist-to-height ratio)(Three years)
- Circulating and antigen-stimulated concentrations of cytokines, chemokines and other inflammatory mediators(Three years)
- Incidence of self-reported acute respiratory infection (upper, lower and both combined)(Three years)
- Body composition: impedance, impedance%, fat mass fat %, and fat-free mass(Three years)
- Physical fitness (maximal oxygen consumption estimated from 20m shuttle run)(Three years)
- Attention-related behavior scores (Connors III)(Three years)
- Incidence of dental caries(Three years)
- Spirometric lung volumes (FEV1 and FVC)(Three years)
- Serum 25-hydroxyvitamin D concentration(Three years)
- Control of asthma, allergic rhinitis and atopic dermatitis(Three years)
- Incidence of bone fracture(Three years)
- Bone mineral density at the radius(Three years)
研究者
Ganmaa Davaasambuu
Assistant Professor
Harvard School of Public Health (HSPH)