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


METHODS
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.


CONCLUSIONS
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; http://clinicaltrials.gov; NCT01694667.
University of California, San Francisco. Electronic address: Stephen.Bent@ucsf.edu.
Stephen
S
Bent
University of California, San Francisco.
Robert L
RL
Hendren
Kennedy Krieger Institute.
Tara
T
Zandi
Kennedy Krieger Institute.
Kiely
K
Law
University of California, San Francisco.
Jae-Eun
JE
Choi
University of California, San Francisco.
Felicia
F
Widjaja
Kennedy Krieger Institute.
Luther
L
Kalb
Kennedy Krieger Institute.
Jay
J
Nestle
Kennedy Krieger Institute.
Paul
P
Law
D002648:Child; D002659:Child Development Disorders, Pervasive / Q000150:complications / Q000188:drug therapy*; D002675:Child, Preschool; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D006801:Humans; D006948:Hyperkinesis / Q000188:drug therapy* / Q000209:etiology; D020407:Internet; D008297:Male; D016896:Treatment Outcome
D015525:Fatty Acids, Omega-3
alternative medicine; autism; hyperactivity; nutritional supplement