Omega-3 Fatty Acids for Autism Treatment

NCT00786799 | Completed Phase 2 Results DMC

• 1 other identifier: 200816175-1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Omega-3 fatty acids are among the most commonly used CAM (Complementary Alternative Medical) therapies, and have been reported to be currently used by 28.7% of children with autism. Two published case series noted that families reported large improvements in the core feature of autism when children were given omega-3 fatty acids. Low levels of omega-3 fatty acids have been noted in children with autism, which suggests normalizing the omega-3 fatty acid levels could produce improvements in the symptoms seen in many children with autism. This study is a 12-week randomized, double blind, placebo-controlled clinical trial for 24 male and female children aged 3 to 8 years with autism. Patients who are currently using omega-3 would need to discontinue omega-3 fatty acids for 8 weeks before they are able to participate in the study. All study participants who meet all inclusion and no exclusion criteria at the initial screening visit and sign the consent form will then complete baseline assessments of the outcome measures (validated instruments of hyperactivity, communication, social interaction, and behavior) and be randomly assigned to 12 weeks of omega-3 fatty acids at a dose of 1 gm per day or an identical placebo. The child's behavior will be measured and evaluated at the MIND Institute at the beginning of the study and at study closing. All study families will come in for a follow-up visit at weeks 4 and 8 to assess medication compliance and side effects to study medication. After 12 weeks of treatment, all outcome measures including laboratory tests and side effect profiles will be repeated. All patients who complete the study will receive a 12-week supply of omega-3. This would also provide patients who were on placebo with active medication. No follow-up visits are needed once the patient finishes the double-blind portion of the study.

Conditions

Autism

Outcome Measures

Primary Outcomes (1)

• Group-specific and Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score (Active Omega-3 Group Only, Placebo Group Only and Comparison Between Groups)

  Hyperactivity subscale of Aberrant Behavior checklist (ABC-H): measure of assessing changes in symptoms of hyperactivity in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. Items are rated on a 4-point scale from "no problem" to "major problem"). ABC-H Subscale Score ranges from 0 (best) to 45 (worst). A negative change signifies improvement.

  Baseline and 1 year

Secondary Outcomes (2)

• Change in Percentage of Serum Omega-3 Fatty Acids

  Baseline and 1 year

• Change in Serum TNFα (Cytokine) Level

  Baseline and 1 year

Study Arms (2)

Omega-3 Fatty Acids

ACTIVE COMPARATOR

Dietary Supplement: Omega-3 Fatty Acids

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Omega-3 Fatty Acids

Interventions

Omega-3 Fatty Acids DIETARY_SUPPLEMENT

Omega-3's are administered in the form of an orange pudding made by Coromega 1 mg of omega-3 fatty acid 2 times per day

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

Omega-3 Fatty Acids

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of autism as defined by DSM-IV TR and scores above the cutoff on the Autism Diagnostic Observation Scale (ADOS) and the Social Communication Questionnaire (SCQ)
• Age three to eight years
• Non-verbal IQ of 50 or above
• Children on a stable medical regimen for the past 2 months and no plans to change medical therapy for the study period

You may not qualify if:

• Individuals with allergy or hypersensitivity to fish or nuts
• Diabetes
• Bleeding disorder, current use of anticoagulant or anti-platelet therapy, or recent surgery
• Clinical evidence of seizure disorder
• Cancer
• Fragile X or other known genetic cause of autism
• Perinatal brain injury
• Evidence for malnutrition seen in abnormal albumin level
• Other serious medical illness
• Current use of omega-3 fatty acids

Sponsors & Collaborators

• University of California, San Francisco: lead
• Autism Speaks: collaborator

Study Sites (1)

UC San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (2)

• Lunsky Y, P Hastings R, Weiss JA, M Palucka A, Hutton S, White K. Comparative Effects of Mindfulness and Support and Information Group Interventions for Parents of Adults with Autism Spectrum Disorder and Other Developmental Disabilities. J Autism Dev Disord. 2017 Jun;47(6):1769-1779. doi: 10.1007/s10803-017-3099-z.

  PMID: 28374207 DERIVED

• Bent S, Bertoglio K, Ashwood P, Bostrom A, Hendren RL. A pilot randomized controlled trial of omega-3 fatty acids for autism spectrum disorder. J Autism Dev Disord. 2011 May;41(5):545-54. doi: 10.1007/s10803-010-1078-8.

  PMID: 20683766 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

Fatty Acids, Omega-3; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; 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

Limitations and Caveats

1. Small sample size which results in a limited power to detect small to moderate treatment effects. 2. Relatively mild level of hyperactivity in both groups.

Results Point of Contact

• Title: Robert L. Hendren, D.O.
• Organization: University of California, San Francisco

robert.hendren@ucsf.edu

415-476-7198

Study Officials

• Stephen Bent, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Robert L Hendren, DO

  UC San Francisco

  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 5, 2008
• First Posted: November 6, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 31, 2012
• Results First Posted: August 31, 2012

Record last verified: 2012-07

Locations

US (1)