Skip to content

Docosahexaenoic Acid in the Treatment of Autism

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00577447
Enrollment
48
Registered
2007-12-20
Start date
2005-10-31
Completion date
2007-11-30
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Keywords

autism, omega-3 fatty acids, docosahexaenoic acid

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

Interventions

DIETARY_SUPPLEMENTdocosahexaenoic acid (DHA)

Capsule containing 200mg of DHA

DIETARY_SUPPLEMENTPlacebo

Placebo capsule containing corn and soybean oil

Sponsors

DSM Nutritional Products, Inc.
CollaboratorINDUSTRY
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Clinical Global Impressions-Improvement Scale6 months

Secondary

MeasureTime frame
Child Development Inventory6 months
Behavior Assessment Scale for Children6 months
Aberrant Behavior Checklist6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026