Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Double-blind Randomized Placebo-controlled Trail

Conditions
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Autism Spectrum Disorders

Intervention / Treatment
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* Other: Aravita including arachidonic acid and docosaheaenoic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo-controlled trial<br> | Other: Aravita including arachidonic acid and docosaheaenoic acid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arachidonic acid, autism spectrum disorders, social interaction, randomized controlled trial, DHA