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

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

Status and phase: Completed; Phase 2

Conditions: Hyperactivity; Autism Spectrum Disorders

Treatments: Drug: Omega-3 Fatty Acids; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01694667

NA_00068694

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children who are participating in Interactive Autism Network (IAN) Research Families
2. Diagnosis of (Autism Spectrum Disorders (ASD) by a professional and Social Communication Question (SCQ) score>12
3. Age 5-8
4. Aberrant Behavior Checklist - Hyperactivity subscale (ABC-H)>20

Exclusion criteria

1. Children in foster care and each parent must affirm that they are the biological or adoptive parent of the child
2. Allergy to fish
3. Bleeding disorder, current use of anticoagulant or anti-platelet therapy, or recent or planned surgery
4. Any major medical illness that interferes with regular school attendance
5. Current or recent (past six months) use of omega-3 fatty acid
6. Siblings with ASD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

Omega-3 Fatty Acids

Active Comparator group

Description:

Omega-3 Fatty Acids: 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

Treatment:

Drug: Omega-3 Fatty Acids

Placebo

Placebo Comparator group

Description:

Placebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily.

Treatment:

Other: Placebo