Clinical trial NCT01694667: Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder
Official title: Effectiveness of Omega-3 Fatty Acids for the Reduction of Hyperactivity in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorders
Hyperactivity
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2012-09-27
Enrollment: 57
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score
timeFrame: Baseline, 6 weeks (3 week value to be collected)
Secondary outcomes:
measure: Change in Aberrant Behavior Checklist - Lethargy Subscale Score
timeFrame: Baseline, Week 6
measure: Change in Aberrant Behavior Checklist - Stereotypy Subscale Score
timeFrame: Baseline, Week 6
measure: Aberrant Behavior Checklist - Irritability Subscale Score
timeFrame: Baseline, Week 6
measure: Aberrant Behavior Checklist - Inappropriate Speech Subscale Score
timeFrame: Baseline, Week 6
measure: Change in Social Responsiveness Scale (SRS) Score
timeFrame: Baseline, Week 6
measure: Change in Clinical Global Impression - Improvement (CGI-I) Score
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Multiple Locations
country: United States
facility: This study is open to continental USA
state: Maryland
Study officials:
affiliation: Kennedy Krieger Institute and Johns Hopkins University
name: Paul A Law, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bent S, Hendren RL, Zandi T, Law K, Choi JE, Widjaja F, Kalb L, Nestle J, Law P. Internet-based, randomized, controlled trial of omega-3 fatty acids for hyperactivity in autism. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):658-66. doi: 10.1016/j.jaac.2014.01.018. Epub 2014 Mar 12.