NCT02735473

Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Fetal Alcohol Spectrum Disorders

Interventions

Type	Name	Description
DRUG	Choline bitartrate
DRUG	Placebo

Timeline

• Start date: 2016-06-01
• Primary completion: 2021-09-10
• Completion: 2021-09-10
• First posted: 2016-04-12
• Last updated: 2022-11-01
• Results posted: 2022-11-01

Locations

1 site across 1 country: United States