Skip to main content
OpenTrials
Completed

NCT Number: NCT01911299

Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fetal Alcohol Spectrum Disorders Alcohol-Induced Disorders Alcohol-Related Disorders Alcohol-related Neurodevelopmental Disorder Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Alcohol Syndrome Fetal Diseases Mental Disorders Partial Fetal Alcohol Syndrome Pregnancy Complications Prenatal Alcohol Exposure Substance-Related Disorders Urogenital Diseases

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Center for Behavioral Teratology, San Diego State University

San Diego, California, 92120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Choline

Dietary Supplement

5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline

placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water

Dietary Supplement

Primary outcomes

  1. Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention

    Time frame: Baseline and 6 weeks

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2013
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.