title: A randomized, placebo controlled trial of omega-3 fatty acids in the treatment of young children with autism.
abstract: BACKGROUND
  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. In the absence of any medications known to improve core symptom domains, parents often use complementary alternative treatments, including omega-3 fatty acid supplements.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  Thirty-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.
  
  
  CONCLUSIONS
  This study does not support high dose supplementation of omega-3 fatty acids in young children with ASD.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01248728. Registered 22 November 2010.
authors: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, M4G 1R8 ON Canada.
authors: Deepali
authors: D
authors: Mankad
authors: Clinical Research Services, Hospital for Sick Children, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
authors: Annie
authors: A
authors: Dupuis
authors: Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.
authors: Sharon
authors: S
authors: Smile
authors: The Hospital for Sick Children, Toronto, Canada.
authors: Wendy
authors: W
authors: Roberts
authors: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, M4G 1R8 ON Canada ; Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada ; Department of Paediatrics, University of Toronto, Toronto, Canada.
authors: Jessica
authors: J
authors: Brian
authors: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, M4G 1R8 ON Canada.
authors: Toni
authors: T
authors: Lui
authors: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, M4G 1R8 ON Canada.
authors: Lisa
authors: L
authors: Genore
authors: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, M4G 1R8 ON Canada.
authors: Dina
authors: D
authors: Zaghloul
authors: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, M4G 1R8 ON Canada.
authors: Alana
authors: A
authors: Iaboni
authors: Division of Gastroenterology, Hepatology and Nutrition, Hospital for Sick Children, Toronto, Canada.
authors: Peggy Margaret A
authors: PM
authors: Marcon
authors: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, M4G 1R8 ON Canada ; Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada ; Department of Paediatrics, University of Toronto, Toronto, Canada.
authors: Evdokia
authors: E
authors: Anagnostou
keywords: Autism spectrum disorder; Complementary alternative treatment; Omega-3; Randomized controlled trial