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Docosahexaenoic Acid in the Treatment of Autism

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ClinicalTrials.gov Identifier: NCT00577447
Recruitment Status : Completed
First Posted : December 20, 2007
Last Update Posted : April 28, 2015
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by:
Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Autism Dietary Supplement: docosahexaenoic acid (DHA) Dietary Supplement: Placebo Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Docosahexaenoic Acid Supplementation in Children With Autism
Study Start Date : October 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Clinical Global Impressions-Improvement Scale [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Robert G. Voigt, MD/ Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00577447     History of Changes
Other Study ID Numbers: 398-05
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders