Omega-3 Fatty Acid Administration in Dialysis Patients

Vanderbilt University

Status and phase

Completed

Phase 2

Conditions

End Stage Renal Disease

Treatments

Dietary Supplement: placebo

Dietary Supplement: fish oil

Study type

Interventional

Funder types

Other

Identifiers

NCT00655525

R21AT003844-01A2 (U.S. NIH Grant/Contract)

080191

Details and patient eligibility

About

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 disease state. We hypothesize that if administered for a period of 3 months, fish oil will improve the chronic uremic inflammation. We further hypothesize that fish oil administration will improve the muscle protein breakdown associated with uremia and inflammation.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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).