Objectives: This double blind placebo controlled trial evaluated the safety and efficacy of omega-3 fatty acid supplementation on hyperactivity and other behaviors in children with autism. The study also investigated whether changes in plasma fatty acid concentration and cytokine markers were associated with behavioral changes in response to treatment.
Methods: Children with ADOS-confirmed autism (n=58) were randomized to receive 12 weeks of omega-3 fatty acid supplementation (625 mg DHA and 875 mg EPA per day) or a soybean oil placebo matched for scent and appearance. Soybean oil provides Omega-6 fatty acids (linoleic acid), but not Omega-3 fatty acids. Plasma fatty acid concentrations and cytokine markers were measured at baseline and again at 12 weeks. Behavioral changes were monitored at three time points (baseline, 6 weeks, and 12 weeks) via the Aberrant Behavior Checklist and PDD-Behavior Inventory. Adverse events and treatment adherence were monitored bi-weekly.
Results: The treatment was well-tolerated by both groups, with no serious adverse events in either group, and no differences between groups in terms of adverse events or side effects. In the unadjusted analysis, the active treatment group demonstrated a significant increase in DHA and EPA in plasma blood concentrations relative to the control group. Adjusting for baseline behavior scores, age, gender, race, and baseline severity of illness by ANCOVA analysis did not reveal significant differences in hyperactivity for the active treatment and control groups. In addition, ANCOVA analyses also did not reveal significant group differences for other associated behavioral problems in autism (e.g. irritability) or for core symptoms of autism.
Conclusions: Omega-3 fatty acid supplementation appears to be safe and effective in increasing DHA and EPA in plasma blood concentration. This study did not demonstrate improvements in hyperactivity, or in other core or associated symptoms of autism.
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