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OpenTrials
Completed

NCT Number: NCT00577447

Docosahexaenoic Acid in the Treatment of Autism

The purpose of this study is to test the hypothesis that dietary supplementation with the omega-3 fatty acid docosahexaenoic acid (DHA) improves the behavior of children with autism.

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

Autism is a neurodevelopmental disability with an increasing prevalence. Traditional medicine does not offer any cures for autism; thus, many parents of children with autism are attracted to complementary and alternative therapies, one of which is dietary supplementation with the long chain polyunsaturated omega-3 fatty acid, docosahexaenoic acid (DHA). DHA is a critical structural lipid of brain cell membranes and differences in brain DHA content may influence synaptic function, particularly in nutritionally-sensitive areas of the brain, such as the cerebellum and hippocampus, which may be brain structures involved in the etiology of autism. This study is a randomized, double-blind, placebo-controlled trial investigating whether DHA supplementation is an effective treatment for children with autism. Eighty children with autism will be randomized to receive 200mg of DHA or placebo for 6 months. Outcome variables will include total plasma fatty acid patterns and scores on parent and investigator-completed behavioral and developmental rating scales at baseline and after 3 and 6 months of supplementation. Differences between groups after 6 months will be evaluated using regression methods. Regression analysis will be used to detect correlations between plasma total fatty acid DHA contents and scores on the various outcome measures. Results from this study will either provide evidence for a breakthrough biomedical treatment alternative for children with autism or evidenced-based advice to desperate parents in regard to their choices of potential treatments for their children with autism

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meet DSM-IV criteria for autistic disorder
  • Age 3 to 10 years

Exclusion criteria

  • Use of a dietary supplement containing DHA within 90 days of study inclusion
  • Medical history of a disorder of lipid metabolism

Treatment and study plan

Docosahexaenoic acid (DHA)

Dietary Supplement

Capsule containing 200mg of DHA

Placebo

Dietary Supplement

Placebo capsule containing corn and soybean oil

Primary outcomes

  1. Clinical Global Impressions-Improvement Scale

    Time frame: 6 months

Secondary outcomes

  1. Child Development Inventory

    Time frame: 6 months

  2. Behavior Assessment Scale for Children

    Time frame: 6 months

  3. Aberrant Behavior Checklist

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • dsm-firmenich Switzerland AG

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Trial of Docosahexaenoic Acid Supplementation in Children With Autism

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 20, 2007
Registry last updated
Apr 28, 2015

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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