Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder
Condition: Autism Spectrum Disorders; Hyperactivity
MeSH terms: Hyperkinesis; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Families and caregivers of children enrolled in the IAN Research between the age 5-8 and with
      an established diagnosis of autism will be invited to participate in the study by e-mail. All
      of these families have previously given consent to be contacted about research opportunities.
      Families who respond to the e-mail recruitment letter will undergo a brief screening process
      to determine if the child has any exclusion criteria and to ensure the child is age 5-8, has
      an autism spectrum disorder, and has elevated baseline levels of hyperactivity. Families will
      undergo an on-line informed consent process including assent of the child. All participants
      will be given an opportunity to speak with a study team member should they have any questions
      about the study or the informed consent process. Participants will sign the informed consent
      using an electronic signature, a process that has been used previously in the IAN network and
      approved by the John's Hopkins Institutional Review Board (IRB). Families meeting all
      eligibility criteria will be randomly assigned and mailed the study medication (omega-3 or
      placebo) which will be administered to children by the parents twice daily for six weeks.
      Both the study medication and the matching placebo are an orange-flavored pudding that is
      specifically designed to be palatable for young children. Assessment of child hyperactivity,
      social functioning, and overall disease severity will be measured at baseline, three and six
      weeks by the parents, who will complete on-line standard questionnaires; ABC, Social
      Responsiveness Scale (SRS), clinical Global Impressions Scale (CGI).

      Side effects will be assessed every week by e-mail, and any report of a side effect will
      immediately be followed-up with telephone contact from the PI. Although omega-3 fatty acids
      are extremely safe in the prescribed doses, the PI or another study physician will still be
      on call 24-hours-a-day, 7-days-a-week to speak to participants about possible adverse events
      or new medical problems (all enrolled families are provided with this 24-hour emergency phone
      contact information).

      As part of the weekly e-mail reminder, parents will also be asked to log the medication that
      was provided to their children each day of the previous week to measure medication adherence.
    

Intervention name(s): Omega-3 Fatty Acids; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).; Placebo packets will have same orange-flavored pudding as active Omega-3 fatty acids comparator with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily.
Other intervention name(s): Omega-3; N-3 Fatty Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment