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

NCT02719665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-07

No results posted yet for this study

Summary

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."

Conditions

  • Peripheral Arterial Disease
  • Claudication
  • Claudication, Intermittent
  • Vascular Occlusion
  • Vascular Calcification
  • Vascular Diseases
  • Osteoarthritis

Interventions

DIETARY_SUPPLEMENT

SPM Emulsion, Dose-modality

Phase 1a Dose-Finding oral SPM administration of increasing dose (15ml, 30ml, and 60ml) by the following schedule: Days 1 to 5: 15 ml; Days 6 to 14: Washout, no SPM administration; Days 15 to 19: 30 ml; Days 20-28: Washout, no SPM administration; Days 29-33: 60 ml

DIETARY_SUPPLEMENT

SPM Softgel, Dose-Modality

Phase 1b Dose-Finding oral softtel SPM administration of two different doses (2 softgel vs 4 softgel) Days 0 to 5: 2 SPM softgel; Days 6 to 21: Washout, no SPM administration; Days 22 to 26: 4 SPM softgel; Days 27-42: Washout, no SPM administration

DIETARY_SUPPLEMENT

Placebo Softgel

Days 43-47: 4 Placebo softgel; Day 48-64 Washout

Sponsors & Collaborators

Principal Investigators

  • Michael Conte, M.D. · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-12-15
Completion
2020-12-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02719665 on ClinicalTrials.gov