Docosahexaenoic Acid in the Treatment of Autism
Primary Purpose
Autism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
docosahexaenoic acid (DHA)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring autism, omega-3 fatty acids, docosahexaenoic acid
Eligibility 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
DHA supplemented group
Placebo group
Outcomes
Primary Outcome Measures
Clinical Global Impressions-Improvement Scale
Secondary Outcome Measures
Child Development Inventory
Behavior Assessment Scale for Children
Aberrant Behavior Checklist
Full Information
NCT ID
NCT00577447
First Posted
December 18, 2007
Last Updated
April 27, 2015
Sponsor
Mayo Clinic
Collaborators
DSM Nutritional Products, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00577447
Brief Title
Docosahexaenoic Acid in the Treatment of Autism
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial of Docosahexaenoic Acid Supplementation in Children With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
DSM Nutritional Products, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
autism, omega-3 fatty acids, docosahexaenoic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
DHA supplemented group
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Dietary Supplement
Intervention Name(s)
docosahexaenoic acid (DHA)
Intervention Description
Capsule containing 200mg of DHA
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule containing corn and soybean oil
Primary Outcome Measure Information:
Title
Clinical Global Impressions-Improvement Scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Child Development Inventory
Time Frame
6 months
Title
Behavior Assessment Scale for Children
Time Frame
6 months
Title
Aberrant Behavior Checklist
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Voigt, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Docosahexaenoic Acid in the Treatment of Autism
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