NCT01911299

Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: San Diego State University · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• Partial Fetal Alcohol Syndrome
• Alcohol-related Neurodevelopmental Disorder
• Prenatal Alcohol Exposure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Choline	5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline
DIETARY_SUPPLEMENT	placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-07-30
• Last updated: 2014-08-01

Locations

1 site across 1 country: United States