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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: Clinical Trial Phase 4 study, sponsored by The Cleveland Clinic.
NCT00578578 is a Phase 4 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 53 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00578578 stopped before completion
NCT00578578 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which eicosapentaenoic acid (EPA), is the first listed.
NCT00578578 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00578578's enrollment target sits among peer trials
53 1229th of 2000 higher than 768 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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