Trial | NCT01653184  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
The effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with age-related macular degeneration.
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 Started
Jul 31
2012
Primary Completion
Mar 31
2014
Study Completion
Mar 31
2014
Last Update
Dec 12
2016
Estimate

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: AREDS 2 Vitamin formula 1g Experimental

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 Experimental

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)

Criteria 

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%.
No Results Posted