Docosahexaenoic Acid in the Treatment of Autism

This study has been completed.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00577447
First received: December 18, 2007
Last updated: May 20, 2011
Last verified: May 2011

December 18, 2007
May 20, 2011
October 2005
September 2007   (final data collection date for primary outcome measure)
Clinical Global Impressions-Improvement Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00577447 on ClinicalTrials.gov Archive Site
  • Child Development Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Behavior Assessment Scale for Children [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autistic Disorder
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
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
Both
3 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577447
398-05
No
Robert G. Voigt, MD/ Principal Investigator, Mayo Clinic
Mayo Clinic
DSM Nutritional Products, Inc.
Principal Investigator: Robert G Voigt, MD Mayo Clinic
Mayo Clinic
May 2011

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