Back to resultsDHA Supplementation in Patients With STGD3
Primary Purpose
Dominantly Inherited Stargardt's Disease (STGD3)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Over the counter DHA/EPA dietary supplementation
Sponsored by
About this trial
This is an interventional prevention trial for Dominantly Inherited Stargardt's Disease (STGD3)
Eligibility Criteria
Inclusion Criteria:
- All Moran Eye Center patients with STGD3
Exclusion Criteria:
- All others
Sites / Locations
- Moran Eye Center, University of Utah
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm, Open Label
Arm Description
Single Arm, Open Label
Outcomes
Primary Outcome Measures
ERG
Secondary Outcome Measures
Visual acuity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00420602
Brief Title
DHA Supplementation in Patients With STGD3
Official Title
Clinical Interventions Against Stargardt Macular Dystrophy: DHA Supplementation in Patients With STGD3
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 21, 2007 (Actual)
Primary Completion Date
December 27, 2017 (Actual)
Study Completion Date
December 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dominantly Inherited Stargardt's Disease (STGD3)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm, Open Label
Arm Type
Other
Arm Description
Single Arm, Open Label
Intervention Type
Dietary Supplement
Intervention Name(s)
Over the counter DHA/EPA dietary supplementation
Intervention Description
1000 mg/day DHA/EPA
Primary Outcome Measure Information:
Title
ERG
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Visual acuity
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All Moran Eye Center patients with STGD3
Exclusion Criteria:
All others
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul S. Bernstein, MD Ph.D.
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moran Eye Center, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Learn more about this trial
DHA Supplementation in Patients With STGD3
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