Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.
详细描述
This project is the third in a series of randomized, double-blind placebo-controlled trials of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). Pre-clinical data suggests that choline may attenuate the cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). This study will evaluate the effects of daily choline supplementation vs. placebo for 9 months. Outcome measures include an elicited imitation memory paradigm, global cognitive functioning, and aspects of executive functioning. The study will also continue to collect safety and tolerability data.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 2 years to 5 years of age
- •Available parent or legal guardian capable of giving informed consent for participation.
- •Documented prenatal alcohol exposure (self-report, social service records, or adoption records).
- •Modified Institute of Medicine (IOM) criteria for Fetal Alcohol Syndrome (FAS), Partial Fetal Alcohol Syndrome (PFAS), or Alcohol-Related Neurodevelopmental Disorder (ARND) (Hoyme, May, et al., 2005).
排除标准
- •Known history of a neurological condition (ex. epilepsy, traumatic brain injury)
- •Known history of a medical condition known to affect brain function.
- •Known history of other neurodevelopmental disorder (ex. autism, Down syndrome)
- •Known history of very low birthweight (<1500 grams)
研究组 & 干预措施
Choline bitartrate
Powdered drink mix containing choline bitartrate 19 mg. per kg.
干预措施: Choline bitartrate (Drug)
Placebo
Powdered drink mix containing matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Elicited Imitation Memory Task - Short Delay Memory Measure: 6 Months
时间窗: Change from baseline to 6 months in percentage correct
Elicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct.
Elicited Imitation Memory Task - Short Delay Memory Measure: 9 Months
时间窗: Change from baseline to 9 months
Elicited Imitation memory paradigm - short delay memory measure at 9 months
次要结局
- Minnesota Executive Function Scale: 6 Months(Change from baseline to 6 months)
- Stanford-Binet Intelligence Scales: 9 Months(Change from baseline to 9 months in IQ points)
- Minnesota Executive Function Scale: 9 Months(Change from baseline to 9 months in t-score points)
- NIH Toolbox Flanker Task: 9 Months(Change from baseline to 9 months in fully-corrected t-score points)
- NIH Toolbox Flanker Task: 6 Months(Change from baseline to 6 months)
- Child Behavior Checklist: 6 Months(Change from baseline to 6 months)
- Child Behavior Checklist: 9 Months(Change from baseline to 9 months in t-score points)