Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorders, Hyperactivity

In brief

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.

Key facts

Study ID

NCT01694667

Run by

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

People needed

57

Starts

2012-09-01

Expected to finish

2013-05-01

Last updated by the study team

2020-08-31

Who can join

Age: 5 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• This study is open to continental USA — Multiple Locations, Maryland, United States

Full record on ClinicalTrials.gov

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