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Omega-3 Fatty Acids for Autism Treatment

This study has been completed.
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00786799
First received: November 5, 2008
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Autism
 Dietary Supplement: Omega-3 Fatty Acids
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled 12-week Study to Investigate the Effect of Omega-3 Fatty Acids on Hyperactivity in Childhood Autism

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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) [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Percentage of Serum Omega-3 Fatty Acids [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]
    Change in percentage calculated as (100% * ((One Year - Baseline)/Baseline)

  • Change in Serum TNFα (Cytokine) Level [ Time Frame: Baseline and 1 year ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omega-3 Fatty Acids Dietary Supplement: Omega-3 Fatty Acids

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

Other Name: Omega-3, N-3 Fatty Acid
Placebo Comparator: Placebo Dietary Supplement: Omega-3 Fatty Acids

Omega-3 Fatty Acids in orange pudding form

1 packet two times per day

Other Name: Omega-3, N-3 Fatty Acid

Detailed Description:

Clinical measures will be used to assess diagnosis and efficacy. All clinical assessments will take place at the M.I.N.D. Institute. Baseline and termination measures will include the Aberrant Behavior Checklist (ABC), Peabody Picture Vocabulary Test (PPVT-III), Expressive Vocabulary Test (EVT), Social Responsiveness Scale (SRS), Behavior Assessment System for Children (BASC), and Clinical Global Impression Improvement (CGI-I). The, the Wechsler Preschool Primary Scale of Intelligence - Revised (WPPSI-R), the Wechsler Intelligence Scale for Children (WISC) or the Stanford-Binet will be administered to measure IQ.

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786799

Locations
United States, California
UC San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Autism Speaks
Investigators
Principal Investigator: Stephen Bent, MD University of California, San Francisco
Principal Investigator: Robert L Hendren, DO UC San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00786799     History of Changes
Other Study ID Numbers: 200816175-1
Study First Received: November 5, 2008
Results First Received: September 14, 2011
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013