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

Phase 2

Active, not recruiting

• Conditions: Fetal Alcohol Spectrum Disorders
• Interventions: Drug: Choline Bitartrate

• Registration Number: NCT05108974
• Lead Sponsor: Jeff Wozniak

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-10-22
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 months choline bitartrate	Choline Bitartrate	Over the 9-month study, participants will receive a total of 3 months of choline bitartrate (19 mg/kg) and a total of 6 months of placebo
6 months choline bitartrate	Choline Bitartrate	Over the 9-month study, participants will receive a total of 6 months of choline bitartrate (19 mg/kg) and a total of 3 months of placebo

Primary Outcome Measures

Name	Time	Method
Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)	Change from baseline to 9 months	Elicited Imitation short-delay memory measure (percent correct for recall)
Stanford-Binet Intelligence Test (SB-5)	Change from baseline to 9 months	Stanford Binet Intelligence Test - 5th Edition
Minnesota Executive Function Scale (MEFS)	Change from baseline to 9 months	Minnesota Executive Function Scale - Early Childhood Version
NIH Toolbox Flanker Test	Change from baseline to 9 months	NIH Toolbox Flanker Inhibitory and Control Test
NIH Toolbox Picture Sequence Memory Test	Change from baseline to 9 months	NIH Toolbox Picture Sequence Memory Test

Secondary Outcome Measures

Name	Time	Method
Child Behavior Checklist (CBCL)	Change from baseline to 9 months	Child Behavior Checklist - Parent Report Version

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States