Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

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

Detailed Description
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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.

Official Title
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Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

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

Intervention / Treatment
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* Dietary Supplement: Choline
* Dietary Supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Choline<br>Liquid glycerophosphocholine (GPC) supplement | Dietary Supplement: Choline<br>* 5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline<br>|
| Placebo Comparator: Placebo<br>Liquid placebo supplement | Dietary Supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choline, Glycerophosphocholine, Choline alphoscerate, Fetal alcohol spectrum disorders, Fetal alcohol syndrome, Partial fetal alcohol syndrome, Alcohol-related neurodevelopmental disorder, Prenatal alcohol exposure, Fetal Alcohol Effects, Pregnancy Complications, Alcohol-Induced Disorders, Alcohol-Related Disorders, Central Nervous System Agents, Therapeutic Uses