Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders

Not Applicable

Completed

• Conditions: Autism Spectrum Disorders
• Interventions: Other: Aravita including arachidonic acid and docosaheaenoic acid

• Registration Number: NCT01154894
• Lead Sponsor: Ashiya University

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 Timeline

• Status Verified: 2008-12
• Study Start: 2009-02
• Primary Completion: 2009-02
• Study Completion: 2009-12
• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-controlled trial	Aravita including arachidonic acid and docosaheaenoic acid	-

Primary Outcome Measures

Name	Time	Method
Aberrant Behavior Checklist-community (ABC)	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

Secondary Outcome Measures

Name	Time	Method
Social Responsiveness Scale (SRS)	pretreatment and at 4 weeks after intervention for 16-weeks trial	The SRS is assessed the severity of social communication impairment in any population.