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Completed

NCT Number: NCT00655525

Omega-3 Fatty Acid Administration in Dialysis Patients

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inflammation Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Fish Oil

Dietary Supplement

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

Other names: eicosapentaenoic acid/docosahexaenoic acid

Placebo

Dietary Supplement

placebo administered orally every day for 3 months

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 10, 2008
Registry last updated
Apr 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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