DHA Supplementation in Patients With STGD3

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT00420602
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arm: 1
• Actual Duration (Months): 123.2
• Patients Per Site Per Month: 0.1

Study Details

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.

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

Study Design

• Study Type: Interventional
• 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: Sep 21, 2007
• Actual Primary Completion Date: Dec 27, 2017
• Actual Study Completion Date: Dec 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Single Arm, Open Label Single Arm, Open Label	Dietary Supplement: Over the counter DHA/EPA dietary supplementation; 1000 mg/day DHA/EPA

Outcome Measures

Primary Outcome Measures

1. ERG [1 year]

Secondary Outcome Measures

1. Visual acuity [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 105 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All Moran Eye Center patients with STGD3

Exclusion Criteria:

• All others

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul S. Bernstein, Professor of Ophthalmology, University of Utah
• ClinicalTrials.gov Identifier: NCT00420602
• Other Study ID Numbers: IRB 19676
• First Posted: Jan 11, 2007
• Last Update Posted: May 9, 2018
• Last Verified: May 1, 2018

• Additional relevant MeSH terms: Stargardt Disease

Study Results

No Results Posted as of May 9, 2018