VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma (VICTORY)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Early childhood asthma/persistent wheeze age 0-3 years
研究概览
简要总结
The overall aim of the study is to develop a nutritional preventive vitamin D supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that supplementation in higher doses than recommended could reduce the risk of disease development.
详细描述
Randomization of 2000 pregnant women to vitamin D of high-dose (3200 IU/day) vitamin D vs placebo on top of the recommended 400 IU/day. Supplementation begins in gestational week 24 (22-26) until 1 week after delivery. Allocation to the trial will be determined based on the pre-interventional maternal blood levels of EPA+DHA with a dried blood screening test. Women with high levels (above 4.7% of total fatty acids) will be assigned to the vitamin D RCT. Maternal blood will be used for genetic, metabolomic and proteomic profiling. A 3-year follow-up of the children with longitudinal registration of parent reported symptoms, diagnoses, medication use, and hospitalizations will be performed. The primary outcome is persistent wheeze or asthma until age 3 years, with predefined analyses of effect modification by maternal genotypes. Secondary outcomes are lower respiratory tract infections, gastrointestinal infections, croup, troublesome lung symptoms, eczema, allergy, bone fractures, developmental milestones, mental health, cognition, and growth until age 3 years. A follow-up on both primary and secondary outcomes is planned after unblinding, from age 3 to 6 years.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant Danish women before week 26 with blood levels of EPA+DHA above 4.7% of total fatty acids
- •No current vitamin D intake above the recommended 400 IU/day
- •No endocrine-, heart-, kidney- or auto-immune disorders
- •No disorders requiring treatment with blood thinning medication
排除标准
- 未提供
结局指标
主要结局
Early childhood asthma/persistent wheeze age 0-3 years
时间窗: 3 years
Defined as either a) parental report of a minimum of 2 wheeze episodes with at least 1 after the child's second birthday and redemption of at least 2 prescriptions of asthma controller medication with at least 1 being after the child's second birthday or b) a minimum of 2 ED visits or hospitalizations due to asthmatic symptoms, and at least 1 of these being after the child's second birthday or c) parental report of physician-diagnosed asthma age 0-3 years Outcome analysis: risk (survival analysis) of persistent wheeze or asthma at age 0-3 years.
次要结局
- Bone fractures age 0-3 years(3 years)
- Atopic/non-atopic wheeze or asthma age 0-3 years(3 years)
- Troublesome lung symptoms age 0-3 years(3 years)
- Wheeze episodes age 0-3 years(3 years)
- Inhaled bronchodilator use from parental reports age 0-3 years(3 years)
- Inhaled bronchodilator prescriptions from medical record checks age 0-3 years(3 years)
- Asthma controller medication use from parental reports age 0-3 years(3 years)
- Asthma controller medication prescriptions from medical record checks age 0-3 years(3 years)
- Asthma hospitalizations or emergency department visits age 0-3 years(3 years)
- Eczema age 0-3 years(3 years)
- Allergic rhinitis age 0-3 years(3 years)
- Food allergy 0-3 years(3 years)
- Lower respiratory tract infections age 0-3 years(3 years)
- Gastrointestinal infections age 0-3 years(3 years)
- Croup age 0-3 years(3 years)
- Fever episodes age 0-3 years(3 years)
- Absences from daycare age 0-3 years(3 years)
- Developmental milestones age 0-3 years(3 years)
- Strength and difficulties at age 3 years(3 years)
- BMI age 0-3 years(3 years)
- Waist circumference age 0-3 years(3 years)
- Persistent wheeze or asthma age 0-6 years(6 years)
- Current asthma at age 6 years(6 years)
- Asthma or wheeze yearly prevalence 0-6 years(6 years)
- Adaptive behavior at 3 years(3 years)
- Atopic/non-atopic asthma at age 6 years(6 years)
- Asthma controller medication 0-6 years(6 years)
- Inhaled bronchodilators age 0-6 years(6 years)
- Asthma hospitalizations or emergency department visits age 0-6 years(6 years)
- Eczema age 0-6 years(6 years)
- Allergic rhinitis age 0-6 years(6 years)
- Food allergy age 0-6 years(6 years)
- Lower respiratory tract infections age 0-6 years(6 years)
- Gastrointestinal infections age 0-6 years(6 years)
- Croup age 0-6 years(6 years)
- Bone fractures age 0-6 years(6 years)
- Strength and difficulties at age 6 years(6 years)
- ADHD symptoms at age 6 years(6 years)
- Psychopathology screening at age 6 years(6 years)
- BMI age 0-6 years(6 years)
- Waist circumference age 0-6 years(6 years)
- ADHD symptoms at age 3 years(3 years)
- Social behavior assessment at age 3 years(3 years)
- Social behavior assessment at age 6 years(6 years)
- Psychopathology screening at age 3 years(3 years)
- Adaptive behavior at 6 years(6 years)
- Cognitive assessment age 0-3 years(3 years)
- Cognitive assessment age 0-6 years(6 years)
研究者
Professor Klaus Bønnelykke
Professor PhD, Head of COPSAC
Copenhagen Studies on Asthma in Childhood