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Trial record 1 of 25 for:    "Stargardt macular degeneration" [DISEASE] OR NCT00254605 [ID-NUMBER] OR NCT01278277 [ID-NUMBER] OR NCT00060749 [ID-NUMBER] OR NCT00346853 [ID-NUMBER] OR NCT00420602 [ID-NUMBER]
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DHA Supplementation in Patients With STGD3

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420602
First Posted: January 11, 2007
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paul S. Bernstein, University of Utah
  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: 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

Resource links provided by NLM:


Further study details as provided by Paul S. Bernstein, University of Utah:

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

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

Enrollment: 11
Study Start Date: August 2006
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm, Open Label
Single Arm, Open Label
Dietary Supplement: Over the counter DHA/EPA dietary supplementation
1000 mg/day DHA/EPA

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 105 Years   (Adult, Senior)
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
Information from the National Library of Medicine

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
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

Responsible Party: Paul S. Bernstein, Professor of Ophthalmology, University of Utah
ClinicalTrials.gov Identifier: NCT00420602     History of Changes
Other Study ID Numbers: IRB 19676
First Submitted: January 10, 2007
First Posted: January 11, 2007
Last Update Posted: April 28, 2017
Last Verified: April 2017