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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol #20120660 | Other Identifier | WIRB |
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| Name | Class |
|---|---|
| Physician Recommended Nutriceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acid | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Monthly for 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Fineman, MD | Mid Atlantic Retina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mid Atlantic Retina- Cherry Hill | Cherry Hill | New Jersey | 08002 | United States | ||
| Mid Atlantic Retina - Bethlehem |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Bethlehem |
| Pennsylvania |
| 18020 |
| United States |
| Mid Atlantic Retina- Hungtindon Valley | Huntingdon Valley | Pennsylvania | 19006 | United States |
| Mid Atlantic Retina- Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |