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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 fatty acid
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Vision loss, omega-3, supplement, age related macular degeneration

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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%.

Sites / Locations

  • Mid Atlantic Retina- Cherry Hill
  • Mid Atlantic Retina - Bethlehem
  • Mid Atlantic Retina- Hungtindon Valley
  • Mid Atlantic Retina- Wills Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental: AREDS 2 Vitamin formula 1g

Eye Omega Advantage 2g

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Change in omega-3 index
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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2012
Last Updated
December 9, 2016
Sponsor
Wills Eye
Collaborators
Physician Recommended Nutriceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01653184
Brief Title
Effect of Omega-3-fatty Acids on Blood Levels Omega-3 Fatty Acids in Patients With Age-related Macular Degeneration
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wills Eye
Collaborators
Physician Recommended Nutriceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, Vision loss, omega-3, supplement, age related macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: AREDS 2 Vitamin formula 1g
Arm Type
Experimental
Arm Description
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
Arm Title
Eye Omega Advantage 2g
Arm Type
Experimental
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in omega-3 index
Description
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.
Time Frame
Monthly for 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Fineman, MD
Organizational Affiliation
Mid Atlantic Retina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid Atlantic Retina- Cherry Hill
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Mid Atlantic Retina - Bethlehem
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18020
Country
United States
Facility Name
Mid Atlantic Retina- Hungtindon Valley
City
Huntingdon Valley
State/Province
Pennsylvania
ZIP/Postal Code
19006
Country
United States
Facility Name
Mid Atlantic Retina- Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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