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

Stephen Bent, Robert L. Hendren, Tara Zandi, Kiely Law, Jae Eun Choi, Felicia Widjaja, Luther Kalb, Jay Nestle, Paul Law

Research output: Contribution to journalArticlepeer-review

61 Scopus citations


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;; NCT 01694667.

Original languageEnglish (US)
Pages (from-to)658-666
Number of pages9
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Issue number6
StatePublished - Jun 2014


  • alternative medicine
  • autism
  • hyperactivity
  • nutritional supplement

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health


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