Docosahexaenoic Acid in the Treatment of Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00577447
Recruitment Status : Completed
First Posted : December 20, 2007
Last Update Posted : April 28, 2015
DSM Nutritional Products, Inc.
Information provided by:
Mayo Clinic

December 18, 2007
December 20, 2007
April 28, 2015
October 2005
September 2007   (Final data collection date for primary outcome measure)
Clinical Global Impressions-Improvement Scale [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00577447 on Archive Site
  • Child Development Inventory [ Time Frame: 6 months ]
  • Behavior Assessment Scale for Children [ Time Frame: 6 months ]
  • Aberrant Behavior Checklist [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
Docosahexaenoic Acid in the Treatment of Autism
A Randomized, Double-Blind, Placebo-Controlled Trial of Docosahexaenoic Acid Supplementation in Children With 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.
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
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dietary Supplement: docosahexaenoic acid (DHA)
    Capsule containing 200mg of DHA
  • Dietary Supplement: Placebo
    Placebo capsule containing corn and soybean oil
  • Active Comparator: 1
    DHA supplemented group
    Intervention: Dietary Supplement: docosahexaenoic acid (DHA)
  • Placebo Comparator: 2
    Placebo group
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2007
September 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
3 Years to 10 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Robert G. Voigt, MD/ Principal Investigator, Mayo Clinic
Mayo Clinic
DSM Nutritional Products, Inc.
Principal Investigator: Robert G Voigt, MD Mayo Clinic
Mayo Clinic
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP