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Effect of Omega-3-fatty Acids on Blood Levels Omega-3 Fatty Acids in Patients With Age-related Macular Degeneration

NCT ID: NCT01653184

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-03-31

Brief Summary

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The effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with age-related macular degeneration.

Detailed Description

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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.

Conditions

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Macular Degeneration

Keywords

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AMD Vision loss omega-3 supplement age related macular degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

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.

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)

Group Type EXPERIMENTAL

Omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Omega-3 fatty acid

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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%.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Physician Recommended Nutriceuticals

INDUSTRY

Sponsor Role collaborator

Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitchell Fineman, MD

Role: PRINCIPAL_INVESTIGATOR

Mid Atlantic Retina

Locations

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Mid Atlantic Retina- Cherry Hill

Cherry Hill, New Jersey, United States

Site Status

Mid Atlantic Retina - Bethlehem

Bethlehem, Pennsylvania, United States

Site Status

Mid Atlantic Retina- Hungtindon Valley

Huntingdon Valley, Pennsylvania, United States

Site Status

Mid Atlantic Retina- Wills Eye Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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Protocol #20120660

Identifier Type: OTHER

Identifier Source: secondary_id

Omega 20120660

Identifier Type: -

Identifier Source: org_study_id