Status:
COMPLETED
Omega-3 Fatty Acid Administration in Dialysis Patients
Lead Sponsor:
Vanderbilt University
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The overall goal of this study is to examine the role of fish oil supplementation in ameliorating the inflammatory state of uremia and the related muscle protein catabolism associated with this diseas...
Eligibility Criteria
Inclusion
- Patients on CHD for more than 6 months;
- Ability to read and sign the consent form;
- Have acceptable dialysis adequacy (Kt/V \> 1.2);
- Use biocompatible hemodialysis membrane;
- Have a patent, well functioning, arteriovenous dialysis access or permanent dialysis catheter (no other option for arteriovenous access);
- Signs of chronic inflammation (average CRP of ≥ 5 mg/L for 3 consecutive measurements)
Exclusion
- Pregnancy;
- Intolerance to the study medication;
- Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
- Diabetes mellitus on insulin therapy;
- Hospitalization within 1 month prior to the study;
- Malfunctioning arterial-venous vascular access (recirculation and/or blood flow \< 500 ml/min);
- Patients receiving steroids (\> 5 mg/day) and/or other immunosuppressive agents;
- Life-expectancy less than 6 months;
- Age less than 18 years old;
- Atrial fibrillation (only for those undergoing the optional Pulse Wave Velocity);
- Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery Doppler).
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00655525
Start Date
April 1 2008
End Date
June 1 2011
Last Update
April 23 2014
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232