- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01653184
Effect of Omega-3-fatty Acids on Blood Levels Omega-3 Fatty Acids in Patients With Age-related Macular Degeneration
December 9, 2016 updated by: Wills Eye
The Effect of Oral Supplementation With Omega-3 Fatty Acids on Serum Omega-3 Levels in Patients With Age-related Macular Degeneration: A Randomized Controlled Trial.
The effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with age-related macular degeneration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There is observational data in the current literature suggesting that the intake of foods high in marine sources of omega-3 fatty acids, such as fish, may lower the risk of developing age-related macular degeneration (AMD).
A large prospective study is underway to determine whether oral supplementation with 1 gram of omega-3 fatty acids is beneficial for subjects with dry AMD.
The purpose of our study is to evaluate the change in serum omega-3 index (blood level of omega-3 fatty acids) after 1 gram of omega-3 fatty acid supplementation versus 2 grams.
Study Type
Interventional
Enrollment (Actual)
30
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
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New Jersey
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Cherry Hill, New Jersey, United States, 08002
- Mid Atlantic Retina- Cherry Hill
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18020
- Mid Atlantic Retina - Bethlehem
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Huntingdon Valley, Pennsylvania, United States, 19006
- Mid Atlantic Retina- Hungtindon Valley
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Philadelphia, Pennsylvania, United States, 19107
- Mid Atlantic Retina- Wills Eye Institute
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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
53 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Have AREDS category 3 or 4 disease.
- Category 3: Many medium sized drusen or one or more large drusen in one or both eyes
- Category 4: Geographic atrophy or choroidal neovascularization in one eye.
Exclusion Criteria:
- Women of child-bearing age with positive urine pregnancy tests or desire to conceive during the course of the study.
- Patients with a known fish allergy.
- Patients currently taking supplementation with omega-3 fatty acids and have an omega-3 index of greater than 4%.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: AREDS 2 Vitamin formula 1g
Patients will receive oral supplementation with the commercially available "AREDS2" vitamin formula (PreserVision AREDS 2 Eye Vitamin and Mineral Supplement.
Bausch + Lomb Incorporated), consisting of vitamins C, E, zinc, lutein, zeaxanthin and 1g of omega-3 fatty acids in the ethyl ester formulation
|
The purpose of our study is to evaluate the change in serum omega-3 index (blood level of omega-3 fatty acids) after 1 gram of omega-3 fatty acid supplementation versus 2 grams.
|
Experimental: Eye Omega Advantage 2g
Patients will receive a similar vitamin combination in the second arm (Eye Omega Advantage® and Macular Vitamin Benefit.
Physician Recommended Nutriceuticals) with 2g of omega-3 fatty acids in the triglyceride formulation (see attached document for supplement details)
|
The purpose of our study is to evaluate the change in serum omega-3 index (blood level of omega-3 fatty acids) after 1 gram of omega-3 fatty acid supplementation versus 2 grams.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in omega-3 index
Time Frame: Monthly for 6 months
|
To determine the change in omega-3 index using an omega-3 index serum test, in patients with dry AMD given the commercially available AREDS2 formula supplementation (containing 1gram of omega-3 fatty acids in ethyl ester formulation) compared to patients given a similar vitamin combination with 2 grams of omega-3 fatty acids.
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Monthly for 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mitchell Fineman, MD, Mid Atlantic Retina
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
July 1, 2012
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
July 25, 2012
First Submitted That Met QC Criteria
July 27, 2012
First Posted (Estimate)
July 30, 2012
Study Record Updates
Last Update Posted (Estimate)
December 12, 2016
Last Update Submitted That Met QC Criteria
December 9, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Omega 20120660
- Protocol #20120660 (Other Identifier: WIRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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