Dietary Supply of Docosahexaenoic Acid (DHA) and 5-methyl-tetrahydro-folate (MTHF) During the Second Half of Pregnancy and Early Infancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 3
- 主要终点
- percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood
研究概览
简要总结
Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. Biochemical measures are determined in maternal blood during pregnancy and in cord blood.
Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years focus on long term effects of supplementation anthropometric development, neurological development and allergy risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnancy
- •gestation <20 week at enrollment
- •intention to deliver in one of the study centers
- •body weight at time of enrollment from 50 kg to 92 kg
排除标准
- •serious chronic illness (eg, diabetes, hepatitis)
- •use fish oil supplements since the beginning of pregnancy
- •use of folate or vitamin B-12 supplements after gestation week 16
研究组 & 干预措施
fish oil + folate
the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA, 150 mg eicosapentaenoic acid and 400 µg MTHF per day from gestational week 22 until delivery
干预措施: fish oil + folate (Dietary Supplement)
placebo
the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women from gestational week 22 until delivery
干预措施: placebo (Dietary Supplement)
folate
the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 400 µg folate (methyltetrahydrofolate)per day from gestational week 22 until delivery
干预措施: folate (Dietary Supplement)
fish oil
the participating women receive a milk based supplement providing vitamins and mineral as recommended for pregnant women and 500 mg DHA and 150 eicosapentaenoic acid per day from gestational week 22 until delivery
干预措施: fish oil (Dietary Supplement)
结局指标
主要结局
percentage contribution of docosahexaenoic acid (DHA) to total phospholipid fatty acids in cord blood
时间窗: labour
the biochemical efficacy of supplementation during pregnancy is tested by measuring the DHA content of cord blood phospholipids, as direct supplementation (fish oil) or increased perfusion of the placenta (MTHF) could both influence this parameter
次要结局
- neurological and cognitive development of the offspring(age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years)
- weight development(age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years)
- life style and diet(age 4 years, 5.5 years, 6.5 years, 7.5 years, 8 years, 9 years, 9.5 years)
- height(age 4 years, 5.5 years, 6.5 years, 8 years, 9.5 years)
- electroencephalography (EEG)(age 8 years and 9.5 years)