Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study

Fetal Alcohol Spectrum Disorders Clinical Trial

— CHOLINE4  

Official title:

Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05108974
• Other study ID #: UMN-1506M74642
• Secondary ID: R01AA024123
• Status: Recruiting
• Phase: Phase 2
• Start date: October 22, 2021
• Est. completion date: August 31, 2026

Study information

• Verified date: December 2023
• Source: University of Minnesota
• Contact: Jeffrey R Wozniak, Ph.D.
• Phone: 612-598-0041
• Email: jwozniak[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.

Description:

This project is the fourth in a series of randomized, double-blind controlled trials of choline bitartrate in children ages 2-5 (under 6) years with prenatal alcohol exposure. Pre-clinical data suggests that choline may attenuate the cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). This study will evaluate the effects of daily choline supplementation in two dosing regimens (3 months choline vs. 6 months choline). Outcome measures include an elicited imitation memory paradigm, IQ measures, and measures of memory and executive functioning, and behavior.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Months to 72 Months

Eligibility

Inclusion Criteria:

• Ages 2.5 years to 5 years old (<6 years of age) at enrollment

• Prenatal alcohol exposure

• Available parent or legal guardian capable of giving informed consent for participation.

Exclusion Criteria:

• History of a neurological condition (ex. epilepsy, traumatic brain injury)

• History of a medical condition known to affect brain function

• Other neurodevelopmental disorder (ex. autism, Down syndrome)

• History of very low birthweight (<1500 grams)

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders

Intervention

Drug:
• Choline Bitartrate
Powdered drink mix for daily consumption

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Jeff Wozniak	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)	Elicited Imitation short-delay memory measure (percent correct for recall)	Change from baseline to 9 months
Primary	Stanford-Binet Intelligence Test (SB-5)	Stanford Binet Intelligence Test - 5th Edition	Change from baseline to 9 months
Primary	Minnesota Executive Function Scale (MEFS)	Minnesota Executive Function Scale - Early Childhood Version	Change from baseline to 9 months
Primary	NIH Toolbox Flanker Test	NIH Toolbox Flanker Inhibitory and Control Test	Change from baseline to 9 months
Primary	NIH Toolbox Picture Sequence Memory Test	NIH Toolbox Picture Sequence Memory Test	Change from baseline to 9 months
Secondary	Child Behavior Checklist (CBCL)	Child Behavior Checklist - Parent Report Version	Change from baseline to 9 months