DHA Supplementation in Patients With STGD3

May 8, 2018 updated by: Paul S. Bernstein, University of Utah

Clinical Interventions Against Stargardt Macular Dystrophy: DHA Supplementation in Patients With STGD3

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Moran Eye Center, University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 105 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All Moran Eye Center patients with STGD3

Exclusion Criteria:

  • All others

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Single Arm, Open Label
Dietary supplement: Over the counter DHA/EPA dietary supplementation
1000 mg/day DHA/EPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ERG
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Paul S. Bernstein, MD Ph.D., University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 21, 2007

Primary Completion (ACTUAL)

December 27, 2017

Study Completion (ACTUAL)

December 27, 2017

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 10, 2007

First Posted (ESTIMATE)

January 11, 2007

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 19676

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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