Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Jeff Wozniak
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)
研究概览
简要总结
This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.
详细描述
This project is the fourth in a series of randomized, double-blind controlled trials of choline bitartrate in children ages 2-5 (under 6) years with prenatal alcohol exposure. 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 in two dosing regimens (3 months choline vs. 6 months choline). Outcome measures include an elicited imitation memory paradigm, IQ measures, and measures of memory and executive functioning, and behavior.
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
- 30 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 2.5 years to 5 years old (<6 years of age) at enrollment
- •Prenatal alcohol exposure
- •Available parent or legal guardian capable of giving informed consent for participation.
排除标准
- •History of a neurological condition (ex. epilepsy, traumatic brain injury)
- •History of a medical condition known to affect brain function
- •Other neurodevelopmental disorder (ex. autism, Down syndrome)
- •History of very low birthweight (<1500 grams)
研究组 & 干预措施
3 months choline bitartrate
Over the 9-month study, participants will receive a total of 3 months of choline bitartrate (19 mg/kg) and a total of 6 months of placebo
干预措施: Choline Bitartrate (Drug)
6 months choline bitartrate
Over the 9-month study, participants will receive a total of 6 months of choline bitartrate (19 mg/kg) and a total of 3 months of placebo
干预措施: Choline Bitartrate (Drug)
结局指标
主要结局
Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)
时间窗: Change from baseline to 9 months
Elicited Imitation short-delay memory measure (percent correct for recall)
Stanford-Binet Intelligence Test (SB-5)
时间窗: Change from baseline to 9 months
Stanford Binet Intelligence Test - 5th Edition
Minnesota Executive Function Scale (MEFS)
时间窗: Change from baseline to 9 months
Minnesota Executive Function Scale - Early Childhood Version
NIH Toolbox Flanker Test
时间窗: Change from baseline to 9 months
NIH Toolbox Flanker Inhibitory and Control Test
NIH Toolbox Picture Sequence Memory Test
时间窗: Change from baseline to 9 months
NIH Toolbox Picture Sequence Memory Test
次要结局
- Child Behavior Checklist (CBCL)(Change from baseline to 9 months)