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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT05108974•Jeff Wozniak

View on ClinicalTrials.gov

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.

Eligibility

Age

2 - 6 years

Sex

ALL

Healthy Volunteers

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)

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

October 22, 2021

Primary Completion Date

July 31, 2026

Completion Date

July 31, 2026

Last Updated

July 31, 2025

Enrollment

ACTUAL participants

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Choline Bitartrate

DRUG

Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure

NCT06847165

Fetal Alcohol Spectrum DisordersAttention Deficit Hyperactivity Disorder

View study

RECRUITINGPHASE2

RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure

NCT04395196

Fetal Alcohol Spectrum DisordersFetal Alcohol Syndrome

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure

RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure

Families Moving Forward Bridges: An Early Intervention for Infants and Toddlers With PAE With or At-risk for FASD

A Study of Parent and Child Emotions in Fetal Alcohol Spectrum Disorder (FASD)

Nutritional Risk Factors for FASD in Ukraine