Phase 2
Completed N=57
Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder
Autism Spectrum Disorder · Hyperactivity
Source: ClinicalTrials.gov NCT01694667 ↗
Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score — -5.3; -3.4 units on a scale
Summary
The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial which will assess changes in hyperactivity in children ages five through eight with an autism spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer this question, this study will assess changes in hyperactivity as measured by the Aberrant Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo. The overwhelming majority of study procedures, including recruitment, informed consent, assessment of inclusion and exclusion criteria, and collection of baseline and outcome measures will take place over the internet.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score |
-5.3; -3.4 | — |
| SECONDARY Change in Aberrant Behavior Checklist - Lethargy Subscale Score |
-2.1; 0.1 | — |
| SECONDARY Change in Aberrant Behavior Checklist - Stereotypy Subscale Score |
-2.0; -0.5 | — |
| SECONDARY Aberrant Behavior Checklist - Irritability Subscale Score |
-2.0; -2.1 | — |
| SECONDARY Aberrant Behavior Checklist - Inappropriate Speech Subscale Score |
-0.6; -0.9 | — |
| SECONDARY Change in Social Responsiveness Scale (SRS) Score |
-2.6; -6.1 | — |
| SECONDARY Change in Clinical Global Impression - Improvement (CGI-I) Score |
12; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Children who are participating in Interactive Autism Network (IAN) Research Families
- Diagnosis of (Autism Spectrum Disorders (ASD) by a professional and Social Communication Question (SCQ) score>12
- Age 5-8
- Aberrant Behavior Checklist - Hyperactivity subscale (ABC-H)>20
Exclusion Criteria
- Children in foster care and each parent must affirm that they are the biological or adoptive parent of the child
- Allergy to fish
- Bleeding disorder, current use of anticoagulant or anti-platelet therapy, or recent or planned surgery
- Any major medical illness that interferes with regular school attendance
- Current or recent (past six months) use of omega-3 fatty acid
- Siblings with ASD
Data sourced from ClinicalTrials.gov (NCT01694667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.