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

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ClinicalTrials.gov Identifier: NCT01154894
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Ashiya University

Tracking Information
First Submitted Date  ICMJE June 30, 2010
First Posted Date  ICMJE July 1, 2010
Last Update Posted Date June 23, 2011
Study Start Date  ICMJE February 2009
Actual 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 ]
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
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 ]
The SRS is assessed the severity of social communication impairment in any population.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Arms  ICMJE 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. doi: 10.1097/JCP.0b013e3182485791.

*   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: June 30, 2010)
13
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 29 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01154894
Other Study ID Numbers  ICMJE KunioYui
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kunio Yui, Ashiya University
Study Sponsor  ICMJE Ashiya University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ashiya University
Verification Date December 2008

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