Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Jennifer D. Thomas, Ph.D. San Diego State University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jennifer Thomas, Associate Director - Center for Behavioral Teratology, San Diego State University, San Diego State University
ClinicalTrials.gov Identifier: NCT01911299    
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:
Layout table for MeSH terms
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
 Choline
Glycerol
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs