Omega-3 Fatty Acid Administration in Dialysis Patients

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Dietary Supplement: fish oil; Dietary Supplement: placebo

• Registration Number: NCT00655525
• Lead Sponsor: Vanderbilt University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-22
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	fish oil	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC)	3 months
A decrease in muscle protein breakdown	3 months

Secondary Outcome Measures

Name	Time	Method
A decrease in concentration of acute phase reactants (serum C-reactive protein and plasma pro-inflammatory cytokines)	3 months
An increase in concentration of nutritional biomarkers (serum albumin and serum prealbumin)	3 months

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States