NCT00577447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

December 18, 2007

Last Update Submit

April 27, 2015

Conditions

Autism

Keywords

autismomega-3 fatty acidsdocosahexaenoic acid

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impressions-Improvement Scale

    6 months

Secondary Outcomes (3)

  • Child Development Inventory

    6 months

  • Behavior Assessment Scale for Children

    6 months

  • Aberrant Behavior Checklist

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

DHA supplemented group

Dietary Supplement: docosahexaenoic acid (DHA)

2

PLACEBO COMPARATOR

Placebo group

Dietary Supplement: Placebo

Interventions

docosahexaenoic acid (DHA)DIETARY_SUPPLEMENT

Capsule containing 200mg of DHA

1
PlaceboDIETARY_SUPPLEMENT

Placebo capsule containing corn and soybean oil

2

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Medical history of a disorder of lipid metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Robert G Voigt, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 20, 2007

Study Start

October 1, 2005

Primary Completion

September 1, 2007

Study Completion

November 1, 2007

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

US(1)