Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders (Fatty acid)
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Autism Spectrum Disorders |
Other: Aravita including arachidonic acid and docosaheaenoic acid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Double-blind Randomized Placebo-controlled Trail |
- 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
- 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.
| Enrollment: | 13 |
| Study Start Date: | February 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Placebo-controlled trial |
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.
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided by Ashiya University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kunio Yui, Ashiya University |
| ClinicalTrials.gov Identifier: | NCT01154894 History of Changes |
| Other Study ID Numbers: | KunioYui |
| Study First Received: | June 30, 2010 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Sawa Hospital: Independent Ethics Committee |
Keywords provided by Ashiya University:
|
arachidonic acid autism spectrum disorders social interaction randomized controlled trial DHA |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013