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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study — CHOLINE4  

Fetal Alcohol Spectrum Disorders Clinical Trial

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

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05108974
Study type Interventional
Source University of Minnesota
Contact Jeffrey R Wozniak, Ph.D.
Phone 612-598-0041
Email jwozniak@umn.edu
Status Recruiting
Phase Phase 2
Start date October 22, 2021
Completion date August 31, 2026
View Details
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