Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders (Fatty acid)
|ClinicalTrials.gov Identifier: NCT01154894|
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : June 23, 2011
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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 or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Other: Aravita including arachidonic acid and docosaheaenoic acid||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Double-blind Randomized Placebo-controlled Trail|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||December 2009|
|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.
Primary Outcome Measures :
- Aberrant Behavior Checklist-community (ABC) [ Time Frame: 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 :
- Social Responsiveness Scale (SRS) [ Time Frame: pretreatment and at 4 weeks after intervention for 16-weeks trial ]The SRS is assessed the severity of social communication impairment in any population.
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