Internet-based, randomized, controlled trial of omega-3 fatty acids for hyperactivity in autism

Abstract

Objective: Preliminary evidence suggests that omega-3 fatty acids may reduce hyperactivity in children with autism spectrum disorder (ASD). We sought to examine the feasibility of a novel, Internet-based clinical trial design to evaluate the efficacy of this supplement.

Method: E-mail invitations were sent to parents of children aged 5 to 8 years enrolled in the Interactive Autism Network. All study procedures, including screening, informed consent, and collection of outcome measures took place over the Internet. The primary outcome measures were parent- and teacher-rated changes in hyperactivity on the Aberrant Behavior Checklist (ABC-H).

Results: During the 6-week recruitment period, 57 children from 28 states satisfied all eligibility criteria and were randomly assigned to 1.3 grams of omega-3 fatty acids or an identical placebo daily for 6 weeks. Outcome assessments were obtained from all 57 participants and 57 teachers, and the study was completed in 3 months. Children in the omega-3 fatty acid group had a greater reduction in hyperactivity (-5.3 points) compared to the placebo group (-2.6 points), but the difference was not statistically significant (1.9-point greater improvement in the omega-3 group, 95% CI = -2.2 to 5.2). Adverse events were rare and not associated with omega-3 fatty acids. Participant feedback was positive.

Conclusion: Internet-based, randomized controlled trials of therapies in children with ASD are feasible and may lead to marked reductions in the time and cost of completing trials. A larger sample size is required to definitively determine the efficacy of omega-3 fatty acids. Clinical trial registration information-Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder; https://ichgcp.net/clinical-trials-registry/NCT01694667" title="See in ClinicalTrials.gov">NCT01694667.

Keywords: alternative medicine; autism; hyperactivity; nutritional supplement.

Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1. Flow Diagram Showing Distribution of Participants at Each Stage

aNote: Participants can screen fail for multiple reasons

Figure 2. Change in Mean Aberrant Behavior Checklist-Hyperactivity (ABC-H) Subscale Scores

Note: During the six week study, mean ABC-H decreased (improved) more in the omega-3 group compared to the placebo group, as rated by both parents (top two lines) and teachers (bottom two lines), but the differences between treatment groups were not statistically significant.