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
  Purpose

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.


Condition Intervention
Autistic Disorder
Dietary Supplement: docosahexaenoic acid (DHA)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Docosahexaenoic Acid Supplementation in Children With Autism

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Clinical Global Impressions-Improvement Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: October 2005
Study Completion Date: November 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
DHA supplemented group
Dietary Supplement: docosahexaenoic acid (DHA)
Capsule containing 200mg of DHA
Placebo Comparator: 2
Placebo group
Dietary Supplement: Placebo
Placebo capsule containing corn and soybean oil

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577447

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
DSM Nutritional Products, Inc.
Investigators
Principal Investigator: Robert G Voigt, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Robert G. Voigt, MD/ Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00577447     History of Changes
Other Study ID Numbers: 398-05
Study First Received: December 18, 2007
Last Updated: May 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
autism
omega-3 fatty acids
docosahexaenoic acid

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014