Objectives: This is a pilot study that has been designed to evaluate the effect of treatment with PUFAS omega-3, DHA and EPA, on oxidative stress and symptoms among children and adolescents with ASD. We hypothesize that 8-week treatment with PUFAS will lead to greater improvement on oxidative stress parameters and ASD clinical features compared to placebo. The study of minors is justified because, if treatment with PUFAS is proven safe and effective, early treatment could help to prevent damage caused by chronic exposure to oxidative stress.
Methods: Crossover multicenter randomized clinical trial controlled with placebo in children (5-11 years) and adolescents (12-17 years). Patients are eligible for inclusion if they meet DSM-IV criteria for Pervasive Developmental Disorders, confirmed if deemed necessary by the Autism Diagnostic Observation Schedule (ADOS). Power sample size calculations are based on previous studies with PUFAS omega3 on children and suggest a sample size of 80 patients.
Study treatment: Participants will be randomized to receive treatment with fish oil with a high concentration of PUFAS omega3 (experimental treatment) or paraffin oil (placebo) during 8 weeks. PUFAS omega-3 daily doses will be EPA 577.5 mg/day + DHA 385 mg/day for patients 5-11 years old and EPA 693 mg /d + DHA 462 mg /d for 12-17 (divided doses, tid). After this, patients will undergo a 2-week wash out phase. During the second 8-week treatment phase, patients receiving placebo will switch to PUFAS omega-3 and vice-versa. Before and after every treatment phase blood draws and clinical evaluations will be performed. Both treatment phases will be double blind. Experimental treatment and placebo will consist on identical soft gelatin capsules. Patients taking other psychoactive medications were permitted to continue doing so at stable doses, except antipsychotics and omega3 supplements. During the trial, subjects were not allowed to start new psychopharmacological adjunctive medication or changing doses of adjunctive treatments.
Outcome measures: Efficacy assessments will be performed on weeks 8, 10, and 18. Safety and tolerability will be assessed weekly. The primary efficacy measure is oxidative stress level measured as level of PUFAS on erythrocyte membrane, total antioxidant oxidative stress, and plasma level of glutathione. Secondary efficacy measures include changes on clinical symptoms.
Results: study is currently in the recruitment phase. Results will be available shortly after recruitment is completed (June 2010).
Conclusions: Ongoing study.