Prenatal Docosahexaenoic Acid (DHA) & Neurofunctional Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Maternal-Infant DHA Equilibrium
研究概览
简要总结
The purpose of this study is to learn how much DHA to give to mothers in order to provide enough to the baby. Researchers will also learn if there are differences in development of the baby up to 12 months after birth.
详细描述
Docosahexaenoic acid (DHA) is an essential nutrient. Our bodies make DHA from the foods we eat. If we eat foods with a lot of DHA, like fatty ocean fish, we have more DHA in our bodies. DHA is found in all cells of the body but is especially high in nerve cells of the brain and eye. Babies get DHA from the mother when they're in the womb. After birth, they can get DHA from breast milk or infant formulas.
This study will enroll pregnant women and follow them and their baby until the baby is 12 months old. Changes in the development of the baby will be tracked. Half of the participants in this study will receive 200mg of DHA to take daily. The other half of participants will receive 800mg of DHA to take daily. Participants, along with the researchers, will not know which dose of DHA they are receiving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Women in their 12th to 20th week of gestation
- •Participants agree to consume the study capsules from enrollment to delivery
- •Healthy weight, overweight and obese women (determined by body mass index; BMI) are eligible
- •Must be available by telephone
排除标准
- •Underweight women and women who exceed 250 lbs at enrollment
- •Women with serious systemic infection, cancer, major organ disease or systemic lupus erythematosus
- •Women with multiple infants or fetal diagnosis of congenital cardiac structural or conduction defects or brain malformations
- •Diagnosis of Type I diabetes, and/or hypertension
- •Reported drug and/or alcohol abuse
- •Unwilling to take capsules, or be contacted by phone
- •Do not understand English
结局指标
主要结局
Maternal-Infant DHA Equilibrium
时间窗: Delivery (birth)
Maternal blood samples and infant cord blood will be collected at delivery and Red Blood Cell (RBC) DHA concentrations between maternal-infant pairs will be compared. Maternal-Infant DHA Equilibrium occurs if newborn cord blood DHA is less than or equal to the mother's DHA at delivery.
次要结局
- Infant Behavioral Assessment(6 months postnatal age)
- Fetal neurodevelopment as indexed by heart rate variability (HRV) and autonomic brain age scores (fABAS)(36 weeks gestational age)
- Infant Neurodevelopment(12 months postnatal age)