Effect of Omega-3-fatty Acids on Blood Levels Omega-3 Fatty Acids in Patients With Age-related Macular Degeneration
This trial is active, not recruiting.
|Treatment||omega-3 fatty acid|
|Collaborator||Physician Recommended Nutriceuticals|
|Start date||July 2012|
|End date||March 2014|
|Trial size||100 participants|
|Trial identifier||NCT01653184, Omega 20120660, Protocol #20120660|
The effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with age-related macular degeneration.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Cherry Hill, NJ||Mid Atlantic Retina- Cherry Hill||no longer recruiting|
|Bethlehem, PA||Mid Atlantic Retina - Bethlehem||no longer recruiting|
|Huntingdon Valley, PA||Mid Atlantic Retina- Hungtindon Valley||no longer recruiting|
|Philadelphia, PA||Mid Atlantic Retina- Wills Eye Institute||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Change in omega-3 index
time frame: Monthly for 6 months
Male or female participants at least 55 years old.
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%.
|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.|
|Principal investigator||Mitchell Fineman, MD|
|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.|
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