Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders

Autism Spectrum Disorders Clinical Trial

— Fatty acid  

Official title:

Double-blind Randomized Placebo-controlled Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154894
• Other study ID #: KunioYui
• Status: Completed
• Phase: N/A
• First received: June 30, 2010
• Last updated: June 22, 2011
• Start date: February 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2008
• Source: Ashiya University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sawa Hospital: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 29 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Child Development Disorders, Pervasive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ashiya University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aberrant Behavior Checklist-community (ABC)	ABC is used to estimate abnormal behavior, including 5 subscales, irritability, social withdrawal, stereotypy, hyperactivity, and inappropriate speech	Pretreatment and at 4 weeks after intervention for 16-weeks trial	Yes
Secondary	Social Responsiveness Scale (SRS)	The SRS is assessed the severity of social communication impairment in any population.	pretreatment and at 4 weeks after intervention for 16-weeks trial	Yes