This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

This study has been completed.
Information provided by (Responsible Party):
Jennifer Thomas, San Diego State University Identifier:
First received: July 26, 2013
Last updated: July 30, 2014
Last verified: July 2014
The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.

Condition Intervention Phase
Fetal Alcohol Spectrum Disorders Fetal Alcohol Syndrome Partial Fetal Alcohol Syndrome Alcohol-related Neurodevelopmental Disorder Prenatal Alcohol Exposure Dietary Supplement: Choline Dietary Supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

Resource links provided by NLM:

Further study details as provided by Jennifer Thomas, San Diego State University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 55
Study Start Date: May 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Choline
Liquid glycerophosphocholine (GPC) supplement
Dietary Supplement: Choline
5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline
Placebo Comparator: Placebo
Liquid placebo supplement
Dietary Supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water

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.

Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01911299

United States, California
Center for Behavioral Teratology, San Diego State University
San Diego, California, United States, 92120
Sponsors and Collaborators
San Diego State University
Principal Investigator: Jennifer D. Thomas, Ph.D. San Diego State University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jennifer Thomas, Associate Director - Center for Behavioral Teratology, San Diego State University, San Diego State University Identifier: NCT01911299     History of Changes
Other Study ID Numbers: CBT-choline-1
Study First Received: July 26, 2013
Last Updated: July 30, 2014

Keywords provided by Jennifer Thomas, San Diego State University:
Fetal alcohol spectrum disorders
Fetal alcohol syndrome
Partial fetal alcohol syndrome
Alcohol-related neurodevelopmental disorder
Prenatal alcohol exposure
Fetal Alcohol Effects
Alcohol-Induced Disorders
Alcohol-Related Disorders
Choline alphoscerate
Pregnancy Complications
Central Nervous System Agents
Therapeutic Uses

Additional relevant MeSH terms:
Fetal Alcohol Spectrum Disorders
Fetal Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Neurodevelopmental Disorders
Pathologic Processes
Mental Disorders
Pregnancy Complications
Substance-Related Disorders
Chemically-Induced Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents processed this record on June 23, 2017