학술논문

Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders 1
Document Type
article
Source
American Journal of Clinical Nutrition. 104(6)
Subject
Pharmacology and Pharmaceutical Sciences
Biomedical and Clinical Sciences
Clinical Research
Neurosciences
Conditions Affecting the Embryonic and Fetal Periods
Clinical Trials and Supportive Activities
Nutrition
Alcoholism
Alcohol Use and Health
Behavioral and Social Science
Mental Health
Perinatal Period - Conditions Originating in Perinatal Period
Intellectual and Developmental Disabilities (IDD)
Pediatric
Fetal Alcohol Spectrum Disorders (FASD)
Brain Disorders
Substance Misuse
Evaluation of treatments and therapeutic interventions
6.1 Pharmaceuticals
Oral and gastrointestinal
Cancer
Mental health
Child
Child
Preschool
Choline
Cognition
Dietary Supplements
Dose-Response Relationship
Drug
Double-Blind Method
Ethanol
Female
Fetal Alcohol Spectrum Disorders
Humans
Learning
Male
Memory
Nutrition Assessment
Patient Compliance
Pregnancy
Prenatal Exposure Delayed Effects
Treatment Outcome
choline
clinical trial
fetal alcohol spectrum disorders
fetal alcohol syndrome
nutrition
prenatal alcohol exposure
supplementation
Engineering
Medical and Health Sciences
Nutrition & Dietetics
Clinical sciences
Nutrition and dietetics
Language
Abstract
BackgroundPrenatal 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.ObjectiveWe 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.DesignIn 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.ResultsCompared 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.ConclusionsFindings 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.