Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders.

Randomized, double-blind, placebo-controlled trial in school-aged children aged 5 to 10 years with confirmed heavy prenatal alcohol exposure/fetal alcohol spectrum disorders. The active choline group included 29 participants, with 26 in the placebo group; the trial was conducted at two U.S. sites and analyzed on an intent-to-treat basis (n = 55).

Children in the active arm received choline 625 mg/day for 6 weeks as an oral glycerophosphocholine liquid concentrate (5.25 mL/day, Nutrasal). The placebo was an equivalent oral liquid matched in taste and consistency.

Choline did not improve memory, executive function, or attention versus placebo over 6 weeks in children with FASDs. For memory, the Time x group interaction was not significant (P = 0.73), and similar null treatment interactions were seen for executive function and attention measures, including Design Fluency (P = 0.31), Spatial Working Memory total errors (P = 0.31), and ADHD quotient accuracy (P = 0.72). Both groups showed some change over time on several tasks, but these improvements were not attributable to choline. Adverse events were more common with choline than placebo (79.3% vs 50.0%, P = 0.03), and no serious adverse events occurred.

The intervention was short (6 weeks) and the sample was modest, which limits power to detect small cognitive effects. Findings are restricted to school-aged children with FASD studied at two U.S. sites, so generalizability is limited. No benefit was seen despite a specific dose and formulation, and the higher rate of adverse events in the choline arm may affect tolerability considerations.