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DHA Supplementation in Patients With STGD3

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ClinicalTrials.gov Identifier: NCT00420602
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Paul S. Bernstein, University of Utah

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Dominantly Inherited Stargardt's Disease (STGD3) Dietary Supplement: Over the counter DHA/EPA dietary supplementation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Interventions Against Stargardt Macular Dystrophy: DHA Supplementation in Patients With STGD3
Actual Study Start Date : September 21, 2007
Actual Primary Completion Date : December 27, 2017
Actual Study Completion Date : December 27, 2017

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Arms and Interventions
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Arm Intervention/treatment
Single Arm, Open Label
Single Arm, Open Label
 Dietary Supplement: Over the counter DHA/EPA dietary supplementation
1000 mg/day DHA/EPA


Outcome Measures
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Primary Outcome Measures :
  1. ERG [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Moran Eye Center patients with STGD3

Exclusion Criteria:

  • All others
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420602


Locations
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United States, Utah
Moran Eye Center, University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Paul S. Bernstein, MD Ph.D. University of Utah
More Information
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Responsible Party: Paul S. Bernstein, Professor of Ophthalmology, University of Utah
ClinicalTrials.gov Identifier: NCT00420602    
Other Study ID Numbers: IRB 19676
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Stargardt Disease
Eye Diseases, Hereditary
Eye Diseases
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn