Kansas University DHA Outcome Study (KUDOS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Percentage of Total Fatty Acids by Weight
研究概览
简要总结
The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.
详细描述
Although numerous trials show benefits of postnatal DHA supplementation for visual acuity and others show benefits for cognitive function and/or attention, studies of increased DHA exposure during fetal life are needed, especially in the US. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 36 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant 8-20 wks at enrollment
- •single fetus
排除标准
- •diabetes (Type I, ii, GDM)
- •hypertension (primary, PIH, preeclampsia/eclampsia)
研究组 & 干预措施
DHA capsules
DHA capsules
干预措施: DHA (Drug)
Placebo capsules
Placebo capsule
干预措施: Placebo capsule (Other)
结局指标
主要结局
Percentage of Total Fatty Acids by Weight
时间窗: at time of birth
Measure of RBC-phospholipid-DHA at Birth
Gestational Age
时间窗: at time of birth
Gestational age of babies at time of birth in days
Birth Weight
时间窗: at time of birth
Weight of baby at birth
Birth Length
时间窗: at time of birth
Length of baby at birth
次要结局
- Gender of Babies(at time of birth)
- Ponderal Index(at time of birth)
- Cord RBC-phospholipid-DHA(at time of birth)
- Head Circumference(at time of birth)
- Preterm Births(births before week 37 of gestation)
研究者
Susan Carlson, PhD
Professor
University of Kansas Medical Center