Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood: Interventional Trial in the COPSAC2010 (Copenhagen Studies on Asthma in Childhood) Birth Cohort
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Persistent wheeze 0 to 3 years of age
研究概览
简要总结
The aim of this study is to prevent asthma and allergies in childhood by supplementation with fish oil (n-3 fatty acids) to the mother during pregnancy. Paticipants are mother and children participating in the ABC-(Asthma Begins in Childhood)cohort. Mothers are recruited during pregnancy and receive supplement with n-3 fatty acids or olive oil (placebo) from week 24 of gestation to 1 week after delivery. The child is followed with acute and planned visit at the research unit and diagnosis of disease is done in the research unit according to predefined algorithms.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women
- •Living in Sealand, Denmark
- •Fluent in Danish Language
- •Willing to let the newborn child participate in the study
排除标准
- •Participating in other clinical trial
研究组 & 干预措施
1
n-3 fatty acid
干预措施: n-3 fatty acid (Dietary Supplement)
2
Olive oil
干预措施: olive oil (Dietary Supplement)
结局指标
主要结局
Persistent wheeze 0 to 3 years of age
时间窗: 3 years
Age at onset of persistent wheeze diagnosed according to predefined algorithm of recurrent troublesome lung symptoms, response to treatment and relapse after withdrawal of treatment
次要结局
- Asthma exacerbations(0-3 years)
- Growth(0 to 3 years of age)
- Neurological development(0-3 years)
- Eczema(0-3 years)
- Airway mucosal immune status(4 weeks and 2 years of age)
- Infections(0-3 years of age)
- Systemic immune status(18 months)
- Allergic sensitization(6 and 18 months of age)