Docosahexaenoic Acid in the Treatment of Autism

Not Applicable

Completed

• Conditions: Autism
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: docosahexaenoic acid (DHA)

• Registration Number: NCT00577447
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-10
• Primary Completion: 2007-09
• Study Completion: 2007-11
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-20
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Meet DSM-IV criteria for autistic disorder
• Age 3 to 10 years

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Exclusion Criteria

• Use of a dietary supplement containing DHA within 90 days of study inclusion
• Medical history of a disorder of lipid metabolism

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo group
1	docosahexaenoic acid (DHA)	DHA supplemented group

Primary Outcome Measures

Name	Time	Method
Clinical Global Impressions-Improvement Scale	6 months

Secondary Outcome Measures

Name	Time	Method
Aberrant Behavior Checklist	6 months
Behavior Assessment Scale for Children	6 months
Child Development Inventory	6 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States