19145
A Randomized, Placebo Controlled Trial of Omega-3 Fatty Acids in the Treatment of Young Children with Autism

Friday, May 15, 2015: 11:30 AM-1:30 PM
Imperial Ballroom (Grand America Hotel)
D. Mankad1, A. Dupuis2, S. Smile3, W. Roberts4, J. A. Brian5, T. B. Lui6, L. Genore7, D. Zaghloul8, A. Iaboni6, M. Marcon9 and E. Anagnostou10, (1)Holland Bloorview Kids Rehabilitation Hospital, Scarborough, ON, Canada, (2)Clinical Research Services, The Hospital for Sick Children, Toronto, ON, Canada, (3)Developmental Paediatrics, Holland Bloorview Kids Rehabilitation Hospital, Toronto, ON, Canada, (4)Integrated Services for Autism and Neurodevelopmental Disorders, Toronto, ON, Canada, (5)Autism Research Centre, Holland Bloorview Kids Rehabilitation Hospital/ U of Toronto, Toronto, ON, Canada, (6)Autism Research Centre, Holland Bloorview Kids Rehabilitation Hospital, Toronto, ON, Canada, (7)Autism Research Centre, Bloorview Research Institute, Toronto, ON, Canada, (8)Autism Research Centrre, Bloorview Research Institute, Toronto, ON, Canada, (9)Pediatrics, The Hospital for Sick Children, Toronto, ON, Canada, (10)Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, ON, Canada
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. 

Objectives:  

The primary objective of this study was to assess whether omega-3 fatty acids (NutraSea-HP) are effective in improving symptom severity and externalizing symptoms in young children with ASD. The secondary objective was to evaluate the effect of omega-3 fatty acids on adaptive functioning and language development and to provide further safety data for the use of omega-3’s in preschool aged children.

Methods:  

We conducted a 6 month, randomized, placebo controlled trial of omega-3 fatty acid supplements (1.5 grams) vs placebo in children 2-5 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).  In a secondary fashion we examined global 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 0-24 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-3’s were relatively well tolerated.  Changes in cytokines during the study did not correlate with treatment response.

Conclusions:  

Based on this study, there is no evidence supporting high dose supplementation of omega-3 fatty acids in young children with ASD.

See more of: Interventions Pharmacologic
See more of: Interventions - Pharmacologic