Clinical trial NCT01911299: Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
Official title: Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fetal Alcohol Spectrum Disorders
Fetal Alcohol Syndrome
Partial Fetal Alcohol Syndrome
Alcohol-related Neurodevelopmental Disorder
Prenatal Alcohol Exposure
Keywords: 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
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 55
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF)
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Center for Behavioral Teratology, San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Jennifer D. Thomas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen TT, Risbud RD, Mattson SN, Chambers CD, Thomas JD. Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders. Am J Clin Nutr. 2016 Dec;104(6):1683-1692. doi: 10.3945/ajcn.116.142075. Epub 2016 Nov 2.