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Trial record 7 of 12 for:    "Stargardt disease"
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DHA Supplementation in Patients With STGD3

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paul S. Bernstein, University of Utah
ClinicalTrials.gov Identifier:
NCT00420602
First received: January 10, 2007
Last updated: September 23, 2011
Last verified: September 2011
History of Changes
  Purpose

We have found that biomarkers of long-term elevated dietary intake of omega-3 fatty acids such as DHA and EPA are inversely associated with severity of disease phenotype in STGD3 patients. Therefore, the purpose of this study is to follow STGD3 patients as they supplement their diets with DHA/EPA.


Condition Intervention
Dominantly Inherited Stargardt's Disease (STGD3)
 Dietary Supplement: Over the counter DHA/EPA dietary supplementation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Interventions Against Stargardt Macular Dystrophy: DHA Supplementation in Patients With STGD3

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • ERG [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: August 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Over the counter DHA/EPA dietary supplementation
    1000 mg/day DHA/EPA
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Moran Eye Center patients with STGD3

Exclusion Criteria:

  • All others
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420602

Locations
United States, Utah
Moran Eye Center, University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Paul S. Bernstein, MD Ph.D. University of Utah
  More Information

No publications provided

Responsible Party: Paul S. Bernstein, Professor of Ophthalmology, University of Utah
ClinicalTrials.gov Identifier: NCT00420602     History of Changes
Other Study ID Numbers: DHA STGD3
Study First Received: January 10, 2007
Last Updated: September 23, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013