Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

Phase 2

Completed

• Conditions: Partial Fetal Alcohol Syndrome; Prenatal Alcohol Exposure; Fetal Alcohol Spectrum Disorders; Fetal Alcohol Syndrome; Alcohol-related Neurodevelopmental Disorder
• Interventions: Dietary Supplement: Choline; Dietary Supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water

• Registration Number: NCT01911299
• Lead Sponsor: San Diego State University

Brief 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-30
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-30
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Confirmed histories of prenatal alcohol exposure (by review of medical, legal, or social service records or maternal report, if available; information about levels and timing of exposure will be inquired, but not necessary for inclusion)
• English as primary language

Exclusion Criteria

• Significant physical (e.g., uncorrected visual impairment, hemiparesis) or psychiatric (e.g., psychosis) disability that would prohibit participation
• History of neurological condition (e.g., epilepsy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Choline	Choline	Liquid glycerophosphocholine (GPC) supplement
Placebo	placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water	Liquid placebo supplement

Primary Outcome Measures

Name	Time	Method
Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention	Baseline and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF)	Baseline and 6 weeks	Parent questionnaires about children's behavioral functioning will assess any behavioral changes over the treatment period.

Trial Locations

Locations (1)

Center for Behavioral Teratology, San Diego State University; 🇺🇸 San Diego, California, United States