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Omega-3 Fatty Acids for Autism Treatment

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ClinicalTrials.gov Identifier: NCT00786799
Recruitment Status : Completed
First Posted : November 6, 2008
Results First Posted : August 31, 2012
Last Update Posted : August 31, 2012
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE November 5, 2008
First Posted Date  ICMJE November 6, 2008
Results First Submitted Date  ICMJE September 14, 2011
Results First Posted Date  ICMJE August 31, 2012
Last Update Posted Date August 31, 2012
Study Start Date  ICMJE August 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2012)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2008)
Hyperactivity subscale of ABC [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2012)
  • Change in Percentage of Serum Omega-3 Fatty Acids [ Time Frame: Baseline and 1 year ]
    Change in percentage calculated as (100% * ((One Year - Baseline)/Baseline)
  • Change in Serum TNFα (Cytokine) Level [ Time Frame: Baseline and 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega-3 Fatty Acids for Autism Treatment
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled 12-week Study to Investigate the Effect of Omega-3 Fatty Acids on Hyperactivity in Childhood Autism
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Omega-3 Fatty Acids
    Intervention: Dietary Supplement: Omega-3 Fatty Acids
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Omega-3 Fatty Acids
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2012)
27
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2008)
24
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00786799
Other Study ID Numbers  ICMJE 200816175-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Autism Speaks
Investigators  ICMJE
Principal Investigator: Stephen Bent, MD University of California, San Francisco
Principal Investigator: Robert L Hendren, DO UC San Francisco
PRS Account University of California, San Francisco
Verification Date July 2012

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