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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

Fetal Alcohol Spectrum Disorders Clinical Trial

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

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.

Clinical Trial Description

This project is the third in a series of randomized, double-blind placebo-controlled trials of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol Spectrum Disorders (FASD). 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 vs. placebo for 9 months. Outcome measures include an elicited imitation memory paradigm, global cognitive functioning, and aspects of executive functioning. The study will also continue to collect safety and tolerability data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02735473
Study type Interventional
Source University of Minnesota
Contact
Status Completed
Phase Phase 2
Start date June 2016
Completion date September 10, 2021
View Details
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