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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014