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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01653184

Enrollment

Registered

2012-07-30

Start date

2012-07-31

Completion date

2014-03-31

Last updated

2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

AMD, Vision loss, omega-3, supplement, age related macular degeneration

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTOmega-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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%.

Design outcomes

Primary

Measure	Time frame	Description
Change in omega-3 index	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026