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

This study has been completed.
Sponsor:
Information provided by:
Ashiya University
ClinicalTrials.gov Identifier:
NCT01154894
First received: June 30, 2010
Last updated: June 22, 2011
Last verified: December 2008
  Purpose

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).


Condition Intervention
Autism Spectrum Disorders
Other: Aravita including arachidonic acid and docosaheaenoic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Randomized Placebo-controlled Trail

Resource links provided by NLM:


Further study details as provided by Ashiya University:

Primary Outcome Measures:
  • Aberrant Behavior Checklist-community (ABC) [ Time Frame: Pretreatment and at 4 weeks after intervention for 16-weeks trial ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: pretreatment and at 4 weeks after intervention for 16-weeks trial ] [ Designated as safety issue: Yes ]
    The SRS is assessed the severity of social communication impairment in any population.


Enrollment: 13
Study Start Date: February 2009
Study Completion Date: December 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo-controlled trial Other: Aravita including arachidonic acid and docosaheaenoic acid
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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided by Ashiya University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kunio Yui, Ashiya University
ClinicalTrials.gov Identifier: NCT01154894     History of Changes
Other Study ID Numbers: KunioYui
Study First Received: June 30, 2010
Last Updated: June 22, 2011
Health Authority: Sawa Hospital: Independent Ethics Committee

Keywords provided by Ashiya University:
arachidonic acid
autism spectrum disorders
social interaction
randomized controlled trial
DHA

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

ClinicalTrials.gov processed this record on August 28, 2014