NCT05108974

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Jeff Wozniak · Academic / Other
• Sex: All
• Age: 30 Months – 72 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Fetal Alcohol Spectrum Disorders

Interventions

Type	Name	Description
DRUG	Choline Bitartrate	Powdered drink mix for daily consumption

Timeline

• Start date: 2021-10-22
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2021-11-05
• Last updated: 2025-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study