Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

Phase 2 Completed 46 enrolled University of Minnesota National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2016-06
Primary completion: 2021-09-10
Completion: 2021-09-10

Outcome

Met primary endpoint

paper participants receiving choline performed 25% better on EI short-delay adjacent pairs (sequential memory) than those on placebo PMID 39956364 ↗

paper with a steeper increase in scores between 6 and 9 mo (ŷ = -10.06; P = 0.03; 95% CI: -19.13, -0.99). PMID 39956364 ↗

Publications

Wozniak JR, Eckerle JK, Gimbel BA, Ernst AM, Anthony ME, Tuominen KA, de Water E, Zeisel SH, Georgieff MK. Choline enhances elicited imitation memory performance in preschool children with prenatal alcohol exposure: a cumulative report of 3 randomized controlled trials. Am J Clin Nutr. 2025 Apr;121(4):921-931. doi: 10.1016/j.ajcnut.2025.02.009. Epub 2025 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Choline Bitartrate	Small molecule	19 mg/kg	—