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Choline Intervention in Children with Fetal Alcohol Spectrum Disorders

  • 19 mars 2017
  • 2 min de lecture

Medicilon is a Preclinical Research Outsourcing (CRO) company. With our more than 10 years experience on preclinical research services, we dedicated to provide our clients with customized preclinical services program in drug metabolism, pharmacokinetics, efficacy studies, and toxicology. We provide our clients a high-quality data and rapid turnaround time to support their drug development, preclinical studies and clinical research and to help them to select the most valuable drug candidates into clinical trials stage. Our preclinical research services consist in three major parts: pharmacokinetics, disease transplantation models and drug safety evaluation. Our services cover all of the aspects including design, in vivo studies, sample analysis, professional data analysis, IACUC review, and the preparation of application materials.

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Prenatal alcohol exposure results in a broad range of neuropsychological and behavioral impairments. Considering the long-lasting problems associated with fetal alcohol spectrum disorders (FASD), the development of effective treatment programs is critical. Choline, an essential nutrient, is important for healthy fetal brain development, and preclinical studies have demonstrated that choline supplementation can attenuate the severity of alcohol-related cognitive impairments. Given this evidence, this project aimed to translate preclinical findings to a clinical population to investigate if choline supplementation can ameliorate the severity of memory, executive function, and attention deficits in children with FASD. The current study was a randomized, double-blind, placebo-controlled clinical trial that explored the effectiveness of a choline intervention for children with FASD ages 5-10 years. 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 daily for 6 weeks, whereas those in the placebo group received an equivalent dose of an inactive placebo treatment. Primary outcomes were assessed at baseline and post-intervention, including performance on neuropsychological measures of memory, executive function, and attention/hyperactivity. Results indicated that participants in the choline group did not differentially improve in cognitive performance in any domain, relative to the placebo group. Dietary choline intake was a marginally significant predictor of memory performance at post-assessment, suggesting a trend towards better memory performance in participants with higher levels of dietary choline intake. Overall, the findings of the present study do not support that choline, adminstered at a dose of 625 mg/day for 6 weeks, is an effective intervention for children with FASD. However, this study is only one of the first to translate preclinical trial findings to a human clinical trial of choline supplementation in FASD. Additional studies are needed to further elucidate whether choline and other nutritional supplements may improve outcome and various parameters which may influence effective translation. Altogether, this study highlights the need for a continued understanding of the role of nutritional status and supplementation in FASD and its contributions to neurocognition.


 
 
 

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