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NCT00578578 · ClinicalTrials.gov registry record · Phase 4
Trial to Study the Effects of Supplementary Omega-3 on Serum C-Reactive Protein Levels
A Phase 4 study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- Phase 4
- Development phase
- 53
- Enrollment target
NCT00578578 is a Phase 4 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 53 participants.
The verdict
NCT00578578, a Phase 4 study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 53 participants
- Enrollment target
Study Summary
To study the anti-inflammatory effects of marine omega-3 fatty acids, also known as n-3 polyunsaturated fatty acids (PUFA), we propose a randomized, double-blinded, prospective, single-center trial to examine the effect of supplementary n-3 PUFA on serum high sensitivity (hs) CRP levels. Inclusion Criteria Age \> 18 hs CRP \>3mg/L and \<10 mg/L Exclusion Criteria Active infection Systemic Inflammatory Disease Autoimmune disorders Systemic Lupus Erythematosus (SLE) Rheumatoid Arthritis (RA) Systemic Sclerosis (Scleroderma) Sjögren's Syndrome Behçet's Syndrome The Vasculitis Syndromes Including: Wegener's granulomatosis Temporal arteritis (Giant cell arteritis) Takayasu's arteritis Henoch-Schönlein purpura Predominantly cutaneous vasculitis (hypersensitivity vasculitis) Sarcoidosis Amyloidosis Currently on warfarin Cr \> 2.0 Fish Allergy Pregnancy or unwillingness to use some form of birth control in women of child-bearing age during the 8 weeks. We will enroll 200 pts. at Willoughby Hills Family Health Center over a 2 month period 100 pts. will receive OMEGA-3, 100 pts. will receive placebo Drug is to be taken over 8 weeks Pt. will return to Willoughby Hills in 8 weeks for a follow-up hsCRP. A brief questionnaire will be completed by the nurse/pt, including vital signs at baseline and follow-up . Primary Outcome: hsCRP levels after 8 weeks of treatment with PUFA
Interventions
- DIETARY_SUPPLEMENT eicosapentaenoic acid (EPA),
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2005-09 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00578578
The ClinicalTrials.gov registry entry for NCT00578578 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which eicosapentaenoic acid (EPA), is the first listed.
NCT00578578 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00578578 about?
NCT00578578 is a clinical study titled "Trial to Study the Effects of Supplementary Omega-3 on Serum C-Reactive Protein Levels". To study the anti-inflammatory effects of marine omega-3 fatty acids, also known as n-3 polyunsaturated fatty acids (PUFA), we propose a randomized, double-blinded, prospective, single-center trial to examine the effect of supplementary n-3 PUFA on serum high sensitivity (hs) CRP levels. Inclusion ...
What is the current status of trial NCT00578578?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 53 participants. The study started on 2005-09. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00578578?
The interventions under investigation include: eicosapentaenoic acid (EPA), (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00578578?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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