The Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Heart Rate
研究概览
简要总结
DHA, a type of fatty acid, is important in early development, both in terms of reproductive physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA has been shown to lower triglycerides and is important to cardiovascular health and autonomic control, lowering heart rate and blood pressure and increasing heart variability. Little is known about how fatty acids impact cardiac control in infants, children or the fetus. Our hypothesis is that maternal DHA supplementation (600 mg/day) will lower fetal HR and increase fetal HRV.
详细描述
We have observed that maternal DHA supplementation during pregnancy results in lower fetal heart rate (HR) and higher heart-rate variability (HRV). In another study, we found that infants on DHA supplemented formula have lower HR. Because DHA supplementation in infancy is associated with improved neurobehavioral outcomes and infants with lower HR and higher vagal control have been found to have improved developmental outcomes, the first aim is to conduct a randomized, placebo-controlled trial to determine whether maternal DHA supplementation during pregnancy results in lower HR and higher HRV in the fetal period. We will document other fetal neurobehaviors (body and breathing movements) as they are hallmarks of fetal well-being and influence HR and HRV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant females 16.0-35.99 years of age who are 12 to 20 weeks gestation at the time of enrollment (by dates or ultrasound)
- •Agree to consume study capsules from enrollment until delivery
- •BMI <40 at baseline or weight does not exceed 300 pounds
- •No serious illnesses likely to confound study outcomes
- •Available by phone
排除标准
- •Less than 16 or greater than 35.99 years of age at enrollment
- •BMI >40 at baseline
- •Any serious illness likely to confound primary study outcomes
- •Expecting multiple infants
- •Diabetes (Type I, II or gestational) at baseline
- •Elevated blood pressure due to any cause (systolic BP >= 140 mm Hg
- •Gestational age at baseline < 12 weeks or > 20 weeks
- •Unable to provide informed consent in English
结局指标
主要结局
Heart Rate
时间窗: 24, 32 and 36 weeks gestational age
Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.
次要结局
- Neonatal Behavioral Assessment Scale (NBAS) Scores(within 2 weeks of delivery)
- Maternal Red Blood Cell (RBC) Phospholipids at Delivery(Time of delivery, 36 weeks to term)
- Cord Blood Phospholipids DHA(Birth)
- Cardiac Conduction Time(Change from Baseline to 2 Months Post-natal)
研究者
Kathleen Gustafson, Ph.D.
Research Assistant Professor
University of Kansas