Omega-3 Fatty Acid Administration in Dialysis Patients

April 22, 2014 updated by: Alp Ikizler, Vanderbilt University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Dietary supplement: placebo
placebo administered orally every day for 3 months
Active Comparator: 1
Dietary supplement: fish oil
2.9 g of fish oil (2:1 EPA:DHA) administered orally every day for 3 months
Other Names:
  • eicosapentaenoic acid/docosahexaenoic acid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Alp Ikizler, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 4, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 10, 2008

Study Record Updates

Last Update Posted (Estimate)

April 23, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080191
  • R21AT003844-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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