THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease

Completed · Not applicable · Has a placebo group

Conditions studied: Peripheral Arterial Disease, Claudication, Claudication, Intermittent, Vascular Occlusion, Vascular Calcification, Vascular Diseases, Osteoarthritis

In brief

The purpose of this study is to understand the effects of fish oil supplement (containing parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which dose of the fish oil supplement is the most effective. The name of the fish oil supplement is "SPM Emulsion."

Key facts

Study ID

NCT02719665

Run by

University of California, San Francisco

People needed

30

Starts

2016-03-01

Expected to finish

2020-12-15

Last updated by the study team

2021-05-07

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy Volunteers:
• Age 20-80
• PAD Patients:
• Mild claudication to rest pain (Rutherford 1-4)
• Resting or exercise ABI < 0.9 or TBI < 0.6
• Age 40 and more
• OA Patients:
• Lower extremity (hip or knee) OA

You may not qualify if…

• PAD, OA Patients and Healthy Volunteers:
• Plan to undergo surgical procedure or PVI for treatment of PAD within one month
• Evidence of active infection
• Hypersensitivity or allergy to fish or seafood
• Already on n-3 PUFA or equivalent
• Chronic liver disease, end-stage renal disease (CKD 5), or chronic inflammatory disorders
• Poorly controlled diabetes (HbA1C > 8%)
• BMI < 20 or >35
• Recent other major surgery or illness within 30 days
• Use of immunosuppressive medications or steroids
• History of organ transplantation
• Pregnancy, or plans to become pregnant, or lactating
• Healthy Volunteers:
• hsCRP > 2mg/L
• Regular aspirin use
• Regular non-steroidal anti-inflammatory drug use

Where it is running

• University of California San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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