Osteoarthritis Clinical Trial
Official title:
THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease
NCT number | NCT02719665 |
Other study ID # | 15-17371 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | December 15, 2020 |
Verified date | May 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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."
Status | Completed |
Enrollment | 30 |
Est. completion date | December 15, 2020 |
Est. primary completion date | December 15, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 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 Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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* Note: There are 36 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Optimal Phase 1b Dose | The smallest dose administered in Phase 1a participants which results in an increase in Resolution Index at least 3 times that of baseline, or the subsequent larger dose resulting in a Resolution Index greater than 2 times that of the preceding does with no increase in side effects at the larger dose. | Baseline, Day 33 | |
Primary | Change in the Resolution Index | Integrated metabolo-lipidomics assessment of SPM pathways: Average concentration of 15-HEPE, 18-HEPE, 4-HDHA, and 17-HDHA in plasma. | Baseline, Day 5 |
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