Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders.
What this study found
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…
- Study & population
- 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.
- Intervention
- Children in the active arm received choline 625 mg/day for 6 weeks as an oral glycerophosphocholine liquid concentrate (5.25 mL/day, Nutrasal).
- Key limitation
- The intervention was short (6 weeks) and the sample was modest, which limits power to detect small cognitive effects.
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Open PDFOriginal abstract
BACKGROUND Prenatal alcohol exposure results in a broad range of cognitive and behavioral impairments. Because of the long-lasting problems that are associated with fetal alcohol spectrum disorders (FASDs), the development of effective treatment programs is critical. Preclinical animal studies have shown that choline, which is an essential nutrient, can attenuate the severity of alcohol-related cognitive impairments. OBJECTIVE We aimed to translate preclinical findings to a clinical population to investigate whether choline supplementation can ameliorate the severity of memory, executive function, and attention deficits in children with FASDs. DESIGN In the current study, which was a randomized, double-blind, placebo-controlled clinical trial, we explored the effectiveness of a choline intervention for children with FASDs who were aged 5-10 y. Fifty-five children with confirmed histories of heavy prenatal alcohol exposure were randomly assigned to either the choline (n = 29) or placebo (n = 26) treatment arms. Participants in the choline group received 625 mg choline/d for 6 wk, whereas subjects in the placebo group received an equivalent dose of an inactive placebo treatment. Primary outcomes, including the performance on neuropsychological measures of memory, executive function, and attention and hyperactivity, were assessed at baseline and postintervention. RESULTS Compared with the placebo group, participants in the choline group did not differentially improve in cognitive performance in any domain. Treatment compliance and mean dietary choline intake were not predictive of treatment outcomes. CONCLUSIONS Findings of the current study do not support that choline, administered at a dose of 625 mg/d for 6 wk, is an effective intervention for school-aged (5-10 y old) children with FASDs. This research provides important information about choline's therapeutic window. Combined with other studies of choline and nutritional interventions in this population, this study emphasizes a further need for the continued study of the role of nutritional status and supplementation in children with FASDs and the contributions of nutrition to neurocognition. This trial was registered at clinicaltrials.gov as NCT01911299.