Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
Primary Purpose
Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Choline
placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders focused on measuring 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
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)
Sites / Locations
- Center for Behavioral Teratology, San Diego State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Choline
Placebo
Arm Description
Liquid glycerophosphocholine (GPC) supplement
Liquid placebo supplement
Outcomes
Primary Outcome Measures
Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention
Secondary Outcome Measures
Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF)
Parent questionnaires about children's behavioral functioning will assess any behavioral changes over the treatment period.
Full Information
NCT ID
NCT01911299
First Posted
July 26, 2013
Last Updated
July 30, 2014
Sponsor
San Diego State University
1. Study Identification
Unique Protocol Identification Number
NCT01911299
Brief Title
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
Official Title
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Choline
Arm Type
Experimental
Arm Description
Liquid glycerophosphocholine (GPC) supplement
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Liquid placebo supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Choline
Intervention Description
5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF)
Description
Parent questionnaires about children's behavioral functioning will assess any behavioral changes over the treatment period.
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer D. Thomas, Ph.D.
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Behavioral Teratology, San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27806977
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.
Results Reference
derived
Learn more about this trial
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
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