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

• Status: Recruiting
• Trial end date: 2026-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeff Wozniak
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Choline

Criteria

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)