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

Macular Degeneration Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653184
• Other study ID #: Omega 20120660
• Secondary ID: Protocol #201206
• Status: Completed
• Phase: N/A
• First received: July 25, 2012
• Last updated: December 9, 2016
• Start date: July 2012
• Est. completion date: March 2014

Study information

• Verified date: December 2016
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with age-related macular degeneration.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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%.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
United States	Mid Atlantic Retina - Bethlehem	Bethlehem	Pennsylvania
United States	Mid Atlantic Retina- Cherry Hill	Cherry Hill	New Jersey
United States	Mid Atlantic Retina- Hungtindon Valley	Huntingdon Valley	Pennsylvania
United States	Mid Atlantic Retina- Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Physician Recommended Nutriceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No