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

Randomized, placebo-controlled pilot trial in preschool-aged children with prenatal alcohol exposure and diagnosed fetal alcohol spectrum disorders in the United States. For the choline 500 mg/day active arm, 10 participants were randomized and 9 were analyzed/completed.

Choline was given as 500 mg/day (1.25 g choline bitartrate) in a powdered, fruit-flavored drink mix mixed with water and taken orally once daily for 9 months. The active regimen was compared with placebo.

Daily choline supplementation at 500 mg for 9 months was feasible and well tolerated in this preschool-aged FASD population. Serum choline and betaine increased significantly versus placebo at all measured time points: choline rose from 7.33 (0.60) to 15.07 (1.60) at 1 month, 15.03 (1.42) at 6 months, and 14.77 (1.09) at 9 months, with placebo values of 8.18 (1.23), 6.88 (0.70), and 7.07 (0.77) (all P <= .004). Betaine also increased, from 54.52 (5.32) at baseline to 121.07 (17.95), 111.90 (19.05), and 122.23 (27.17), versus placebo values of 68.91 (13.95), 58.22 (8.75), and 49.58 (6.89) (P = .04, .03, and .04). Phosphatidylcholine did not differ meaningfully, and no serious adverse events occurred; fishy body odor was the main supplement-related complaint.

This was a small pilot study with only 10 randomized participants in the active arm and 9 analyzed/completed, limiting precision and generalizability. The 9-month duration and biomarker-focused outcomes support feasibility and target engagement but do not establish clinical efficacy on neurodevelopmental endpoints. Results may also be less generalizable beyond preschool-aged children with FASD in a specialized clinic setting.