Choline supplementation in children with fetal alcohol spectrum disorders has high feasibility and tolerability.

Double-blind, randomized, placebo-controlled trial; 20 children aged 2.5 to 4.9 years with prenatal alcohol exposure and FASD.

Choline 500 mg per day (as 1.25 g choline bitartrate), for nine months; oral daily dose delivered as a fruit-flavored drink mix, mixed with four ounces of water.

Feasibility and tolerability of 500 mg/day choline for nine months established in young children with FASD. Adverse events were minimal and similar to placebo except fishy body odor in the choline group. No serious adverse events occurred. Compliance was high (82-87%) with 85% completing the trial. Serum choline and betaine increased in the choline group vs placebo; no changes in phosphatidylcholine or sphingomyelin. Larger efficacy trials are underway to determine cognitive benefits; dosing chosen to reach choline sufficiency.

Small sample size (n=20 randomized; 17 completed), Phase I design; nine-month duration; reliance on parent-reported compliance; potential unblinding due to odor; single-site study; not designed to assess efficacy.