Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation: a Randomized, Double-Blind, Placebo Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- allergic eczema
研究概览
简要总结
The incidence of allergic diseases has increased and a relation between allergy and dietary fatty acids has been proposed. Modulation of the maternal immune function during pregnancy may have an impact on future clinical outcomes in the child. The aim of this study was to determine the effects of omega (ω) - 3 long-chain polyunsaturated fatty acid (LCPUFA) supplementation during pregnancy and lactation on the development of allergic disease (i.e., allergic eczema) in the child at 2 years of age. Pregnant women with allergic disease in their immediate family were supplemented daily with 2.7 g ω-3 LCPUFA (n=70) or 2.8 g soybean-oil as placebo (n=75) from gestational week (gw) 25 until the third month of breastfeeding. Skin prick tests, detection of circulating specific IgE antibodies and clinical examinations of the infants were performed at 3, 6, 12 and 24 months of age. The mothers and children were monitored regarding immune modulatory effects during the entire study period.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant woman, at 25 weeks of gestation, with allergic symptoms (rhinitis, conjunctivitis, eczema, asthma or food allergy) herself or the father to be or an older sibling
排除标准
- •Soy allergy
- •Fish allergy
- •Treatment with anti-coagulation
- •Commercial omega-3 supplementation
结局指标
主要结局
allergic eczema
时间窗: 2 years
次要结局
- changes in laboratory parameters such as prostaglandins and cytokines associated to the intervention and the primary outcome(25th gestational week, at partus and 12 months after partus for the mothers, in cord blood at 3, 12 and 24 months for the children)