Docosahexaenoic Acid in the Treatment of Autism

Mayo Clinic

Status: Completed

Conditions: Autism

Treatments: Dietary Supplement: docosahexaenoic acid (DHA); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00577447

398-05

Details and patient eligibility

About

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.

Full 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

Enrollment: 48 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

DHA supplemented group

Treatment:

Dietary Supplement: docosahexaenoic acid (DHA)

2

Placebo Comparator group

Description:

Placebo group

Treatment:

Dietary Supplement: Placebo