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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Physician Recommended Nutriceuticals
Information provided by (Responsible Party):
Wills Eye
ClinicalTrials.gov Identifier:
NCT01653184
First received: July 25, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Macular Degeneration
Dietary Supplement: Omega-3 fatty acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Change in omega-3 index [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653184

Locations
United States, New Jersey
Mid Atlantic Retina- Cherry Hill
Cherry Hill, New Jersey, United States, 08002
United States, Pennsylvania
Mid Atlantic Retina - Bethlehem
Bethlehem, Pennsylvania, United States, 18020
Mid Atlantic Retina- Hungtindon Valley
Huntingdon Valley, Pennsylvania, United States, 19006
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Physician Recommended Nutriceuticals
Investigators
Principal Investigator: Mitchell Fineman, MD Mid Atlantic Retina
  More Information

No publications provided

Responsible Party: Wills Eye
ClinicalTrials.gov Identifier: NCT01653184     History of Changes
Other Study ID Numbers: Omega 20120660, Protocol #20120660
Study First Received: July 25, 2012
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Wills Eye:
AMD
Vision loss
omega-3
supplement
age related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014