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Omega-3 Fatty Acid Administration in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00655525
First received: April 4, 2008
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
End Stage Renal Disease
 Dietary Supplement: fish oil
Dietary Supplement: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acid Administration in Dialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • A decrease in pro-inflammatory cytokine production (TNF-alpha) by peripheral blood mononuclear cells (PBMC) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • A decrease in muscle protein breakdown [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A decrease in concentration of acute phase reactants (serum C-reactive protein and plasma pro-inflammatory cytokines) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • An increase in concentration of nutritional biomarkers (serum albumin and serum prealbumin) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: April 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655525

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

No publications provided

Responsible Party: Alp Ikizler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00655525     History of Changes
Other Study ID Numbers: 080191, R21AT003844-01A2
Study First Received: April 4, 2008
Last Updated: January 21, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Vanderbilt University:
inflammation
end stage renal disease

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

ClinicalTrials.gov processed this record on May 19, 2013