Abstract
BackgroundAutism spectrum disorder (ASD) is a neurodevelopmental disorder affecting more than 1% of children. It is characterized by social communication deficits and repetitive behaviors/restricted interests. In the absence of any medications known to improve core symptom domains, parents often use complementary alternative treatments, including omega-3 fatty acid supplements.MethodsWe conducted a 6-month, randomized, placebo controlled trial of omega-3 fatty acid supplements (1.5 g) vs placebo in children 2 to 5 years of age with ASD. Primary outcome measures included the autism composite score of the Pervasive Developmental Disorders Behavioral Inventory (PDDBI) and the externalizing problems score of the Behavior Assessment System for Children (BASC-2). Secondary outcome measures included clinical global improvement (Clinical Global Impression-Improvement (CGI-I)), adaptive function (Vineland Adaptive Behavior Scale (VABS-II)), and language gains (Preschool Language Scale (PLS-4)), as well as safety. Exploratory analysis investigated potential correlations between changes in cytokine profiles and treatment response.ResultsThirty-eight participants were randomized in a 1:1 fashion. There was no significant difference between groups on the 0- to 24-week change in PDDBI autism composite scores (p = 0.5). There was a significant group by week interaction on the BASC-2 externalizing problem score, with participants randomized to the treatment group demonstrating worsening scores (p = 0.02). There was no statistically significant week by group effect on either adaptive function (p = 0.09) or language (p = 0.6). Omega-3s were relatively well tolerated. Changes in cytokines during the study did not significantly correlate with treatment response.ConclusionsThis study does not support high dose supplementation of omega-3 fatty acids in young children with ASD.Trial registrationClinicaltrials.gov NCT01248728. Registered 22 November 2010.Electronic supplementary materialThe online version of this article (doi:10.1186/s13229-015-0010-7) contains supplementary material, which is available to authorized users.
Highlights
Autism spectrum disorder (ASD) is a neurodevelopmental disorder affecting more than 1% of children
Omega-3 fatty acids are a special class of polyunsaturated fatty acids and include alpha-linoleic acid (ALA), docosahexaenoic acid (DHA), and eisosapentaenoic acid (EPA)
There is accumulating data to support that EPA and DHA are important for brain structure and function and have been advocated for the treatment of multiple neurodevelopmental disorders including mood disorders, schizophrenia, Attention Deficit Hyperactivity Disorder (ADHD), and ASD
Summary
Autism spectrum disorder (ASD) is a neurodevelopmental disorder affecting more than 1% of children. It is characterized by social communication deficits and repetitive behaviors/restricted interests. Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by social communication deficits and repetitive behaviors/restricted interests [1]. There is accumulating data to support that EPA and DHA are important for brain structure and function and have been advocated for the treatment of multiple neurodevelopmental disorders including mood disorders, schizophrenia, ADHD, and ASD. EPA’s importance for the brain’s development in utero is unclear, but colostrum and breast milk do contain EPA [8,9]; it plays a significant role in brain function, and its derivatives are key regulators of immune endocrine and cardiovascular function [10]. Several other mechanisms of action have been hypothesized for, including change in neurotransmitter binding and gene expression, and anti-inflammatory actions [11,12,13]
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