We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Omega-3 Fatty Acid Administration in Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00655525
Recruitment Status : Completed
First Posted : April 10, 2008
Last Update Posted : April 23, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Dietary Supplement: fish oil Dietary Supplement: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acid Administration in Dialysis Patients
Study Start Date : April 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: eicosapentaenoic acid/docosahexaenoic acid
Placebo Comparator: 2 Dietary Supplement: placebo
placebo administered orally every day for 3 months

Outcome Measures

Primary Outcome Measures :
  1. A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC) [ Time Frame: 3 months ]
  2. A decrease in muscle protein breakdown [ Time Frame: 3 months ]

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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655525

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Alp Ikizler, MD Vanderbilt University Medical Center
More Information

Responsible Party: Alp Ikizler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00655525     History of Changes
Other Study ID Numbers: 080191
R21AT003844-01A2 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

Keywords provided by Alp Ikizler, Vanderbilt University:
end stage renal disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency