Clinical trial NCT00577447: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: autism
omega-3 fatty acids
docosahexaenoic acid
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2007-12-20
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Clinical Global Impressions-Improvement Scale
timeFrame: 6 months
Secondary outcomes:
measure: Child Development Inventory
timeFrame: 6 months
measure: Behavior Assessment Scale for Children
timeFrame: 6 months
measure: Aberrant Behavior Checklist
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robert G Voigt, MD
role: PRINCIPAL_INVESTIGATOR
References: