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

NCT01694667 | Completed Phase 2 Results DMC

• 1 other identifier: NA_00068694
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorders; Hyperactivity

Outcome Measures

Primary Outcomes (1)

• Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score

  The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from "0=no problem" to "3=major problem." Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The hyperactivity subscale is comprised of 16 items. The outcome measure is the change from baseline to 6 weeks. The total score ranges from 0 to 48.

  Baseline, 6 weeks (3 week value to be collected)

Secondary Outcomes (6)

• Change in Aberrant Behavior Checklist - Lethargy Subscale Score

  Baseline, Week 6

• Change in Aberrant Behavior Checklist - Stereotypy Subscale Score

  Baseline, Week 6

• Aberrant Behavior Checklist - Irritability Subscale Score

  Baseline, Week 6

• Aberrant Behavior Checklist - Inappropriate Speech Subscale Score

  Baseline, Week 6

• Change in Social Responsiveness Scale (SRS) Score

  Baseline, Week 6

Study Arms (2)

Omega-3 Fatty Acids

ACTIVE COMPARATOR

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

Drug: Omega-3 Fatty Acids

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Omega-3 Fatty Acids DRUG

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).

Also known as: Omega-3, N-3 Fatty Acid

Omega-3 Fatty Acids

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• University of California, San Francisco: collaborator

Study Sites (1)

This study is open to continental USA

Multiple Locations, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 24839884 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Spasm

Interventions

Fatty Acids, Omega-3; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Stephen Bent
• Organization: University of California, San Francisco

Stephen.Bent@ucsf.edu

415-221-4810

Study Officials

• Paul A Law, M.D.

  Kennedy Krieger Institute and Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: September 27, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: August 31, 2020
• Results First Posted: June 16, 2014

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)