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Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders (Fatty acid)

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aravita including arachidonic acid and docosaheaenoic acid
Sponsored by
Ashiya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring arachidonic acid, autism spectrum disorders, social interaction, randomized controlled trial, DHA

Eligibility Criteria

6 Years - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of high functioning autistic disorder or Asperger's Disorder. Free of any medical or comorbid psychiatric disorders.

Exclusion Criteria:

  • Any medical treatment for other psychiatric disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Placebo-controlled trial

    Arm Description

    Outcomes

    Primary Outcome Measures

    Aberrant Behavior Checklist-community (ABC)
    ABC is used to estimate abnormal behavior, including 5 subscales, irritability, social withdrawal, stereotypy, hyperactivity, and inappropriate speech

    Secondary Outcome Measures

    Social Responsiveness Scale (SRS)
    The SRS is assessed the severity of social communication impairment in any population.

    Full Information

    First Posted
    June 30, 2010
    Last Updated
    June 22, 2011
    Sponsor
    Ashiya University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01154894
    Brief Title
    Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders
    Acronym
    Fatty acid
    Official Title
    Double-blind Randomized Placebo-controlled Trail
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ashiya University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In a double-blind, placebo-controlled 16-week trial investigators administered daily doses of either youths with autism spectrum disorders.ARA and DHA supplementation significantly improved communication as well as social withdrawal symptoms. This pilot study provides the first evidence that supplementation with larger ARA doses added to DHA improve impaired social interaction in youths with Autism Spectrum Disorders (ASD).
    Detailed Description
    We recruited 13 individuals who met the DSM-IV criteria for a diagnosis of high functioning autistic disorder (n=1) or Asperger's Disorder (n=12),corroborated by the Autism Diagnostic Interview-Revised. Participants were free of any medical or comorbid psychiatric disorders. Other inclusion criteria included weigh of at least 16 kg, either a verbal or performance intelligence quotient (IQ) above 80, and a score greater than 10 on the social withdrawal subscale of the Aberrant Behavior Checklist-Community.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorders
    Keywords
    arachidonic acid, autism spectrum disorders, social interaction, randomized controlled trial, DHA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo-controlled trial
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Aravita including arachidonic acid and docosaheaenoic acid
    Intervention Description
    Nine of 13 Participants were treated with 6 capsules of Aravita per day for 16-week trial, remaining 4 participants aged under 12 years received 3 capsules per day.
    Primary Outcome Measure Information:
    Title
    Aberrant Behavior Checklist-community (ABC)
    Description
    ABC is used to estimate abnormal behavior, including 5 subscales, irritability, social withdrawal, stereotypy, hyperactivity, and inappropriate speech
    Time Frame
    Pretreatment and at 4 weeks after intervention for 16-weeks trial
    Secondary Outcome Measure Information:
    Title
    Social Responsiveness Scale (SRS)
    Description
    The SRS is assessed the severity of social communication impairment in any population.
    Time Frame
    pretreatment and at 4 weeks after intervention for 16-weeks trial

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    29 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of high functioning autistic disorder or Asperger's Disorder. Free of any medical or comorbid psychiatric disorders. Exclusion Criteria: Any medical treatment for other psychiatric disorders

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22370992
    Citation
    Yui K, Koshiba M, Nakamura S, Kobayashi Y. Effects of large doses of arachidonic acid added to docosahexaenoic acid on social impairment in individuals with autism spectrum disorders: a double-blind, placebo-controlled, randomized trial. J Clin Psychopharmacol. 2012 Apr;32(2):200-6. doi: 10.1097/JCP.0b013e3182485791.
    Results Reference
    derived

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    Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders

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