Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT01911299

Recruitment Status : Completed

First Posted : July 30, 2013

Last Update Posted : August 1, 2014

Sponsor:

Information provided by (Responsible Party):

Jennifer Thomas, San Diego State University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	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

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	55 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
Study Start Date :	May 2013
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fetal Alcohol Spectrum Disorders

Drug Information available for: Choline chloride Choline bitartrate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

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.

Eligibility Criteria

Information from the National Library of Medicine

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

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911299

Locations

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United States, California
Center for Behavioral Teratology, San Diego State University
San Diego, California, United States, 92120

Sponsors and Collaborators

San Diego State University

Investigators

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Principal Investigator:	Jennifer D. Thomas, Ph.D.	San Diego State University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2016 Nov 2.

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Responsible Party:	Jennifer Thomas, Associate Director - Center for Behavioral Teratology, San Diego State University, San Diego State University
ClinicalTrials.gov Identifier:	NCT01911299 History of Changes
Other Study ID Numbers:	CBT-choline-1
First Posted:	July 30, 2013 Key Record Dates
Last Update Posted:	August 1, 2014
Last Verified:	July 2014

Keywords provided by Jennifer Thomas, San Diego State University:


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

Additional relevant MeSH terms:

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Fetal Alcohol Spectrum Disorders Disease Syndrome Neurodevelopmental Disorders Pathologic Processes Mental Disorders Fetal Diseases Pregnancy Complications Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Ethanol	Choline Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs Lipotropic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents Lipid Regulating Agents Nootropic Agents

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