Clinical Trial: Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

Brief Summary: The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.

Detailed Summary: Despite the known damaging effects of alcohol on the developing fetus and the presence of warning labels on alcoholic beverages, many pregnant women continue to drink alcohol. The consequences include a range of physical, neurological, and behavioral effects referred to as fetal alcohol spectrum disorders (FASD). Unfortunately, there are currently no comprehensive treatments for individuals with FASD. This pilot study will examine whether a nutritional intervention could reduce the severity of cognitive deficits associated with prenatal alcohol exposure. Choline is an essential nutrient, necessary for brain and behavioral development. Animal studies have shown that prenatal or early postnatal choline supplementation can lead to long-lasting cognitive enhancement. Similarly, choline supplementation improves cognitive outcomes among rats exposed to alcohol during development, even when administered postnatally and after alcohol exposure has occurred. The present experiment translates these findings to a clinical population of individuals exposed to heavy prenatal alcohol exposure. Subjects will be randomly assigned to receive daily choline supplementation or placebo control for a period of 6 weeks (approximately 20 subjects per group). Performance on neuropsychological tasks that measure cognitive functioning will be measured prior to treatment and at 6 weeks. These data will provide important information regarding a potential nutritional intervention for fetal alcohol spectrum disorders.
Sponsor: San Diego State University

Current Primary Outcome: Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention [ Time Frame: Baseline and 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF) [ Time Frame: Baseline and 6 weeks ]

Parent questionnaires about children's behavioral functioning will assess any behavioral changes over the treatment period.


Original Secondary Outcome: Same as current

Information By: San Diego State University

Dates:
Date Received: July 26, 2013
Date Started: May 2013
Date Completion:
Last Updated: July 30, 2014
Last Verified: July 2014