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

Running, not enrolling · Phase 2

Conditions studied: Fetal Alcohol Spectrum Disorders

In brief

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.

Key facts

Study ID

NCT05108974

Run by

Jeff Wozniak

People needed

62

Starts

2021-10-22

Expected to finish

2027-07-31

Last updated by the study team

2026-07-08

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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