Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-28 @ 1:33 AM
Study NCT ID:
NCT01154894
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2010-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders
Sponsor:
Ashiya University
Organization:
Study Overview
Official Title:
Double-blind Randomized Placebo-controlled Trail
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fatty acid
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: