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

Wills Eye

Status: Completed

Conditions: Macular Degeneration

Treatments: Dietary Supplement: Omega-3 fatty acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01653184

Omega 20120660

Protocol #20120660 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental: AREDS 2 Vitamin formula 1g

Experimental group

Description:

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

Treatment:

Dietary Supplement: Omega-3 fatty acid

Eye Omega Advantage 2g

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Omega-3 fatty acid