65665
document
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 . 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 ; http : //clinicaltrials.gov ; NCT01694667 .
65666
Intervention_Pharmacological
omega-3 fatty acids
65667
Intervention_Pharmacological
omega-3 fatty acids
65668
Intervention_Educational
E-mail invitations
65669
Intervention_Educational
study procedures , including screening , informed consent , and collection of outcome measures took place over the Internet
65670
Intervention_Pharmacological
omega-3 fatty acids
65671
Intervention_Control
an identical placebo
65672
Intervention_Pharmacological
omega-3 fatty acid
65673
Intervention_Control
placebo
65674
Intervention_Pharmacological
omega-3 group
65675
Intervention_Pharmacological
omega-3 fatty acids .
65676
Intervention_Pharmacological
omega-3 fatty acids .
65677
Intervention_Pharmacological
information-Omega-3 Fatty Acids
65678
Outcome_Physical
hyperactivity
65679
Outcome_Physical
hyperactivity
65680
Outcome_Other
efficacy
65681
Outcome_Physical
parent- and teacher-rated changes in hyperactivity on the Aberrant Behavior Checklist ( ABC-H ) .
65682
Outcome_Physical
hyperactivity
65683
Outcome_Adverse-effects
Adverse events
65684
Outcome_Other
feedback
65685
Outcome_Other
efficacy
65686
Participant_Condition
hyperactivity in autism .
65687
Participant_Age
children
65688
Participant_Condition
autism spectrum disorder ( ASD ) .
65689
Participant_Age
children aged 5 to 8 years
65690
Participant_Sample-size
57
65691
Participant_Age
children
65692
Participant_Age
children
65693
Participant_Condition
ASD