Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-04 @ 8:59 AM
Study NCT ID:
NCT02096757
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2014-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
The Use of Fish Oil to Reduce Inflammation Caused by a Peripheral Vascular Intervention
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OMEGA-PVI
Brief Summary:
Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve will improve systemic inflammation and patency of peripheral vascular intervention (PVI).
Detailed Description:
The OMEGA-PVI trial is a double-blind, randomized (2:1 active:placebo), placebo-controlled trial with 30 patients aged ≥ 40 years with PAD. Eligible patients will be screened according to specified inclusion and exclusion criteria. All patients will be treated per our current practice as reflected in the American Heart Association Practice guidelines on PAD. n-3 PUFA supplementation will be achieved with 4 capsules of Pro-Omega twice daily (Nordic Naturals, Watsonville, California, USA), corresponding to a total of 4.4g/day given prior to and immediately after the operation. Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. The placebo group will take the same number of capsules containing inactive substance (soybean; Nordic Naturals), designed to be the same color and shape as the treatment capsules. Blood draws, questionnaires, and ultrasounds will be done periodically. Specific measurements will include established markers of inflammation and resolution of inflammation, as well as ultrasound measures of PVI patency. The study proposed here has the potential to provide important new insights on the role of nutritional interventions in PAD, as well as to improve outcomes related to surgical revascularization.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: