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

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ClinicalTrials.gov Identifier: NCT01653184
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : December 12, 2016
Sponsor:
Collaborator:
Physician Recommended Nutriceuticals
Information provided by (Responsible Party):
Wills Eye

July 25, 2012
July 30, 2012
December 12, 2016
July 2012
March 2014   (Final data collection date for primary outcome measure)
Change in omega-3 index [ Time Frame: Monthly for 6 months ]
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.
Same as current
Complete list of historical versions of study NCT01653184 on ClinicalTrials.gov Archive Site
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Effect of Omega-3-fatty Acids on Blood Levels Omega-3 Fatty Acids in Patients With Age-related Macular Degeneration
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Macular Degeneration
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: 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
    Intervention: Dietary Supplement: Omega-3 fatty acid
  • 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)
    Intervention: Dietary Supplement: Omega-3 fatty acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
100
March 2014
March 2014   (Final data collection date for primary outcome measure)

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%.
Sexes Eligible for Study: All
55 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01653184
Omega 20120660
Protocol #20120660 ( Other Identifier: WIRB )
No
Not Provided
Plan to Share IPD: No
Wills Eye
Wills Eye
Physician Recommended Nutriceuticals
Principal Investigator: Mitchell Fineman, MD Mid Atlantic Retina
Wills Eye
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP