Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911299
• Other study ID #: CBT-choline-1
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2013
• Last updated: July 30, 2014
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol-related Neurodevelopmental Disorder
• Disease
• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• Mental Disorders Diagnosed in Childhood
• Partial Fetal Alcohol Syndrome
• Prenatal Alcohol Exposure
• Syndrome

Intervention

Dietary Supplement:
• Choline
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

Locations

Country	Name	City	State
United States	Center for Behavioral Teratology, San Diego State University	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention		Baseline and 6 weeks	No
Secondary	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.	Baseline and 6 weeks	No