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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 30, 2010
Last Updated Date	June 22, 2011
Start Date ^ICMJE	February 2009
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 30, 2010)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01154894 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 30, 2010)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders
Official Title ^ICMJE	Double-blind Randomized Placebo-controlled Trail
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Autism Spectrum Disorders
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Placebo-controlled trial Intervention: Other: Aravita including arachidonic acid and docosaheaenoic acid
Publications *	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.
* 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
Enrollment ^ICMJE	13
Completion Date	December 2009
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	6 Years to 29 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01154894
Other Study ID Numbers ^ICMJE	KunioYui
Has Data Monitoring Committee	No
Responsible Party	Kunio Yui, Ashiya University
Study Sponsor ^ICMJE	Ashiya University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Ashiya University
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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