Double-blind Trial of Phosphatidylcholine Supplementation During Pregnancy: Impact on Attention and Social Withdrawal at 4 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Behavior rated on the Child Behavior Checklist.
研究概览
简要总结
The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women improves early brain development with improved brain-related development during the first four years of life. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcome is the child's behavior at four years of age as reported by the primary caregiver. Secondary outcomes include motor development, socio-emotional development, language development, and cognitive development. Potential contributors beyond the supplement, including maternal stress and placental function will also be assessed.
详细描述
Choline is an essential nutrient that can be found in foods, such as egg yolks, liver, and other meats. It is important for the composition and repair of normal cellular membranes, normal brain function, and normal cardiovascular function. Research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development. Additionally, adequate prenatal choline levels may have long-lasting positive effects on cognitive function, including memory. However, sufficient research has not been done on the effects of choline on pregnant women and their unborn babies. This study will evaluate the safety and effectiveness of taking choline supplements during pregnancy, and whether taking choline during pregnancy will have an effect on infant development.
Participants in this double-blind study will be randomly assigned to receive either placebo or 1250 mg of choline daily throughout pregnancy, until delivery. Vital signs will be taken, potential side effects will be assessed, and study medication will be given at each visit. Blood samples will be taken at enrollment and approximately at weeks 20, 28, 32. Children will be followed and assessed until 4 years of age.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •General Health: Other than pregnancy related illnesses, physically healthy expectant mothers
- •ages 18-45 years
- •prepregnancy BMI>18 and <45
排除标准
- •Prior history of fetal death
- •Current personal history of chronic infections, including HIV
- •Current personal or family history out to first degree relatives of
- •Trimethylaminuria
- •Homocystinuria
- •Primary language other than English or Spanish
- •Evidence of noncompliance
研究组 & 干预措施
Participants will take placebo
Participants will take placebo. Corn oil every day in place of choline
干预措施: Placebo (Drug)
Drug: Choline
Participants will take 4500 mg of phosphatidylcholine twice per day, the equivalent of approximately 1250 mg of choline per day until delivery
干预措施: Choline (Drug)
结局指标
主要结局
Behavior rated on the Child Behavior Checklist.
时间窗: 4 Years of age
Our primary behavioral outcome is behavior as measured by the Child Behavior Checklist at 4 years of age.
次要结局
未报告次要终点