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

June 30, 2010
June 22, 2011
February 2009
February 2009   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01154894 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders
Double-blind Randomized Placebo-controlled Trail

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Autism Spectrum Disorders
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.
Experimental: Placebo-controlled trial
Intervention: Other: Aravita including arachidonic acid and docosaheaenoic acid
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.
 
Completed
13
December 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
6 Years to 29 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01154894
KunioYui
No
Kunio Yui, Ashiya University
Ashiya University
Not Provided
Not Provided
Ashiya University
December 2008

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