Omega-3 Fatty Acid Administration in Dialysis Patients

Vanderbilt University38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

End Stage Renal Disease

Interventions

fish oilDIETARY_SUPPLEMENT

2.9 g of fish oil (2:1 EPA:DHA) administered orally every day for 3 months

placeboDIETARY_SUPPLEMENT

placebo administered orally every day for 3 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC)

Time frame: 3 months

A decrease in muscle protein breakdown

Time frame: 3 months

Secondary Outcomes

A decrease in concentration of acute phase reactants (serum C-reactive protein and plasma pro-inflammatory cytokines)

Time frame: 3 months

An increase in concentration of nutritional biomarkers (serum albumin and serum prealbumin)

Time frame: 3 months

Data from ClinicalTrials.gov

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