Docosahexaenoic Acid in the Treatment of Autism

Autism Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Trial of Docosahexaenoic Acid Supplementation in Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577447
• Other study ID #: 398-05
• Status: Completed
• Phase: N/A
• First received: December 18, 2007
• Last updated: April 27, 2015
• Start date: October 2005
• Est. completion date: November 2007

Study information

• Verified date: April 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Dietary Supplement:
• docosahexaenoic acid (DHA)
Capsule containing 200mg of DHA
• Placebo
Placebo capsule containing corn and soybean oil

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impressions-Improvement Scale		6 months	No
Secondary	Child Development Inventory		6 months	No
Secondary	Behavior Assessment Scale for Children		6 months	No
Secondary	Aberrant Behavior Checklist		6 months	No