Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Side Effects of Choline Bitartrate
研究概览
简要总结
The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.
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
- •Available parent or legal guardian capable of participating in informed consent process
- •Documented history of heavy prenatal alcohol exposure (self-report, social service records, or adoption records) or presence of facial dysmorphology characteristic of FASD or both
- •Evidence of cognitive deficit in at least one neurocognitive domain
排除标准
- •History of neurological condition (ex. epilepsy, cerebral palsy, traumatic brain injury)
- •History of medical condition known to affect brain function
- •History of other neurodevelopmental disorder (ex. autism, down syndrome)
- •History of very low birthweight (<1500 grams)
- •History of prenatal exposure to drugs other than alcohol, nicotine, and caffeine
研究组 & 干预措施
Choline Bitartrate
Choline Bitartrate supplementation
干预措施: Choline bitartrate (Drug)
Placebo
Placebo for choline bitartrate supplementation
干预措施: Placebo for choline bitartrate (Dietary Supplement)
结局指标
主要结局
Side Effects of Choline Bitartrate
时间窗: Baseline, 6 months, & 9 months
Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.
Mullen Scales of Early Learning - Early Learning Composite
时间窗: Baseline and 9 months
The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details.
次要结局
- Elicited Imitation Task Memory(Baseline, 6 months, and 9 months)
- Evoked Response Potentials Microvolts(Baseline, 6 months, and 9 months)
- Evoked Response Potential - Negative Component Latency(Baseline, 6 months, and 9 months)