Effect of Omega-3-fatty Acids on Blood Levels Omega-3 Fatty Acids in Patients With Age-related Macular Degeneration
This study is currently recruiting participants.
Verified July 2012 by Wills Eye
Sponsor:
Wills Eye
Collaborator:
Physician Recommended Nutriceuticals
Information provided by (Responsible Party):
Wills Eye
ClinicalTrials.gov Identifier:
NCT01653184
First received: July 25, 2012
Last updated: July 27, 2012
Last verified: July 2012
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
Drug Information available for:
Omega-3 Fatty Acids
U.S. FDA Resources
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: | June 2013 |
| Estimated Primary Completion Date: | February 2013 (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 Neutriceuticals) 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 | Recruiting |
| Cherry Hill, New Jersey, United States, 08002 | |
| Contact: N Senderowitsch 800-331-6634 ext 1537 research@midatlanticretina.com | |
| Principal Investigator: Mitchell Fineman, MD | |
| United States, Pennsylvania | |
| Mid Atlantic Retina - Bethlehem | Recruiting |
| Bethlehem, Pennsylvania, United States, 18020 | |
| Contact: N Senderowitsch 800-331-6634 ext 1537 research@midatlanticretina.com | |
| Principal Investigator: Mitchell Fineman, MD | |
| Mid Atlantic Retina- Hungtindon Valley | Recruiting |
| Huntingdon Valley, Pennsylvania, United States, 19006 | |
| Contact: N Senderowitsch 800-331-6634 ext 1537 research@midatlanticretina.com | |
| Principal Investigator: Mitchell Fineman, MD | |
| Mid Atlantic Retina- Wills Eye Institute | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: N Senderowitsch 800-331-6634 ext 1537 research@midatlanticretina.com | |
| Principal Investigator: Mitchell Fineman, MD | |
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: | July 27, 2012 |
| 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 May 23, 2013