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OpenTrials
Completed

NCT Number: NCT01154894

Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders

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).

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Key information

Age range

6 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aravita including arachidonic acid and docosaheaenoic acid

Other

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 outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ashiya University

Other

Registry information

Official study title

Double-blind Randomized Placebo-controlled Trail

Acronym: Fatty acid

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 1, 2010
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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