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

Sponsor

Wills Eye (Other)

Overall Status

Completed

CT.gov ID

NCT01653184

Collaborator

Physician Recommended Nutriceuticals (Industry)

Enrollment

Locations

Arms

Duration (Months)

7.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Dietary Supplement: Omega-3 fatty acid	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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	Dietary Supplement: 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.
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)	Dietary Supplement: 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.

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

Dietary Supplement: 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.

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)

Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts 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%.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mid Atlantic Retina- Cherry Hill	Cherry Hill	New Jersey	United States	08002
2	Mid Atlantic Retina - Bethlehem	Bethlehem	Pennsylvania	United States	18020
3	Mid Atlantic Retina- Hungtindon Valley	Huntingdon Valley	Pennsylvania	United States	19006
4	Mid Atlantic Retina- Wills Eye Institute	Philadelphia	Pennsylvania	United States	19107