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

Not Applicable

Completed

• Conditions: Macular Degeneration
• Interventions: Dietary Supplement: Omega-3 fatty acid

• Registration Number: NCT01653184
• Lead Sponsor: Wills Eye

Brief Summary

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

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-30
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-09
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: AREDS 2 Vitamin formula 1g	Omega-3 fatty acid	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
Eye Omega Advantage 2g	Omega-3 fatty acid	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)

Primary Outcome Measures

Name	Time	Method
Change in omega-3 index	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.

Trial Locations

Locations (4)

Mid Atlantic Retina- Cherry Hill; 🇺🇸 Cherry Hill, New Jersey, United States

Mid Atlantic Retina - Bethlehem; 🇺🇸 Bethlehem, Pennsylvania, United States

Mid Atlantic Retina- Hungtindon Valley; 🇺🇸 Huntingdon Valley, Pennsylvania, United States

Mid Atlantic Retina- Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States