Trial to Study the Effects of Supplementary Omega-3 on Serum C-Reactive Protein Levels
Public ClinicalTrials.gov record NCT00578578. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Protocol for a Randomized, Placebo-Controlled, Double-Blinded Trial to Study the Effects of Supplementary Omega-3 Fatty Acids on Serum C-Reactive Protein Levels
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00578578
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 53 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 19 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2005
- Primary completion
- May 31, 2007
- Completion
- Jul 31, 2007
- Last update posted
- Dec 20, 2007
2005 – 2007
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cleveland Clinic Willoughby Hills Family Health Center | Willoughby Hills | Ohio | 44094 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00578578, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 20, 2007 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00578578 live on ClinicalTrials.gov.