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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

November 5, 2008
July 31, 2012
August 2008
September 2009   (final data collection date for primary outcome measure)
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.
Hyperactivity subscale of ABC [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00786799 on ClinicalTrials.gov Archive Site
  • 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 ]
Secondary outcome measures include established measures of communication, social reciprocity, behavior, and changes in free fatty acids levels and markers of inflammation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Omega-3 Fatty Acids for Autism Treatment
A Randomized, Double-Blind, Placebo-Controlled 12-week Study to Investigate the Effect of Omega-3 Fatty Acids on Hyperactivity in Childhood Autism

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autism
  • 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
  • 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
  • Active Comparator: Omega-3 Fatty Acids
    Intervention: Dietary Supplement: Omega-3 Fatty Acids
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Omega-3 Fatty Acids
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
3 Years to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00786799
200816175-1
Yes
University of California, San Francisco
University of California, San Francisco
Autism Speaks
Principal Investigator: Stephen Bent, MD University of California, San Francisco
Principal Investigator: Robert L Hendren, DO UC San Francisco
University of California, San Francisco
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP