Omega-3 Fatty Acids For Treatment Of Young Children With Autism (OMG)

NCT01248728 | Completed Phase 2 Results

• 1 other identifier: 09-018
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot, randomized, placebo-controlled trial of omega-3 fatty acids in autism. Autism, originally described by Kanner in 1943, is among the most severe of neurodevelopmental disorders. It is a Pervasive Developmental Disorder (PDD) affecting social and communicative functions and is also characterized by repetitive behaviors/restricted interests. It is also frequently accompanied by significant aggression, self-injury, irritability and hyperactivity, making care for these individuals an even greater challenge for families or institutional settings. Autism severely impacts the affected individual and family members, causing life-long functional impairment. In this protocol the investigators will use the terms "autism" and "autism spectrum disorder (ASD)" interchangeably to refer to Autistic disorder, Asperger Syndrome and PDD-Not Otherwise Specified (NOS).

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Clinical Trial; Omega-3 Fatty Acids; Toddlers

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score

  The PDDBI measures autism symptomology. The autism composite score was used as the primary outcome measure for autism symptom severity. PDDBI Autism Composite Scale Range: Minimum Range = 10 (lower autism symptom severity) Maximum Range = 100 (higher autism symptom severity) The Autism Composite is calculated from the sum of T-scores of the Sensory/Perceptual Approach Behaviours, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains subtracted by the sum of T-scores of the Social Approach Behaviours, and Expressive Language domain then converted into the Autism Composite as a T-score. Mean change between baseline and week 24 is reported. A negative change indicates improvement

  Baseline and 24 Weeks

• Change From Baseline in the Behaviour Assessment System for Children (BASC-2) - Externalizing Problems Composite

  The BASC-2 externalizing problems composite measures hyperactivity and aggressive behaviours. Primary Outcome domain: Externalizing Problems composite Externalizing Problems Composite T-Score Range: Minimum Range: 10 (lower externalizing problems) Maximum Range: 120 (higher externalizing problems) The Externalizing Problems composite is computed from the sum of t-scores from the hyperactivity and aggression subscales then converted into the externalizing problems composite t-score. Mean change between baseline and week 24 is reported. A negative change indicates improvement.

  Baseline and 24 Weeks

Secondary Outcomes (3)

• Number of Participants Classified as Responders by the Clinical Global Impression - Improvement (CGI-I)

  24 weeks

• Change From Baseline in the Vineland Adaptive Behavioral Scales (VABS) - Adaptive Functioning Composite

  Baseline and 24 Weeks

• Change From Baseline in the Preschool Language Scale (PLS-4) - Total Language

  Baseline and 24 Weeks

Study Arms (2)

Omega-3 Fatty Acids

ACTIVE COMPARATOR

Children will be administered 3.75ml of the liquid formulation of Nutra Sea high-EPA (HP) (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2.

Dietary Supplement: Omega-3 Fatty Acids

Placebo

PLACEBO COMPARATOR

Children will be administered 3.75ml of the liquid formulation of Placebo. The starting dose will be 1.875ml and the dose will be doubled on week 2.

Dietary Supplement: Placebo

Interventions

Omega-3 Fatty Acids DIETARY_SUPPLEMENT

Children will be administered 3.75ml of the liquid formulation of Nutra Sea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.

Also known as: Nutra Sea HP

Omega-3 Fatty Acids

Placebo DIETARY_SUPPLEMENT

Children will be administered 3.75ml of the liquid formulation of Placebo. The starting dose will be 1.875ml and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.

Also known as: Placebo Comparator

Placebo

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female outpatients 2-5 years of age.
• Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV) criteria. DSM-IV criteria for an autism spectrum disorder, (Autistic disorder, Asperger syndrome or PDD-NOS) will be established by a clinician with expertise with individuals with ASD based on parent interview, Autism Diagnostic Observation Schedule (ADO) and Autism Diagnostic Interview (ADI-R)
• If already receiving stable non pharmacologic educational, behavioral, dietary and or/ natural health product interventions during the preceding 3 months prior to Screening, will not electively initiate new or modify ongoing interventions for the duration of the study unless the child's condition is worsening or their turn comes up on the treatment waiting list.
• Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigator.
• The parents must be able to speak and understand English sufficiently to allow for the completion of all study assessments.

You may not qualify if:

• Patients born prior to 35 weeks gestational age.
• Patients with any primary psychiatric diagnosis other than autism at Screening. We are aware the most primary psychiatric disorders are unlikely to be diagnosed in this age group
• Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain.
• Patients with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease, or coagulation deficits.
• Patients taking psychoactive medication(s) (e.g.,stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clonidine).
• Patients that have been off pharmacotherapy for less than 6 weeks.
• Patients who are participating in another clinical trial
• Patients on anticoagulants
• Patients who know that they will initiate or change nonpharmacologic interventions during the course of the study.
• Patients unable to tolerate venipuncture procedures for blood sampling.
• Patients taking Omega-3 supplements who have not discontinued treatment for six weeks prior to entering into the study.
• Patients who have allergies to any of the ingredients in omega-3 (study product) or the placebo.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• The Hospital for Sick Children: collaborator

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

Related Publications (1)

• Mankad D, Dupuis A, Smile S, Roberts W, Brian J, Lui T, Genore L, Zaghloul D, Iaboni A, Marcon PM, Anagnostou E. A randomized, placebo controlled trial of omega-3 fatty acids in the treatment of young children with autism. Mol Autism. 2015 Mar 21;6:18. doi: 10.1186/s13229-015-0010-7. eCollection 2015.

  PMID: 25798215 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Evdokia Anagnostou
• Organization: Holland Bloorview Kids Rehabilitation Hospital

eanagnostou@hollandbloorview.ca

416-425-6220

Study Officials

• Evdokia Anagnostou, M.D.

  Holland Bloorview Kids Rehabilitation Hospital

  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: November 22, 2010
• First Posted: November 25, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: July 16, 2025
• Results First Posted: May 18, 2016

Record last verified: 2025-07

Locations

CA (1)