Omega-3 Fatty Acid Administration in Dialysis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Omega-3 Fatty Acid Administration in Dialysis Patients

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Dietary Supplement: fish oil
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Dietary Supplement: fish oil<br>* 2.9 g of fish oil (2:1 EPA:DHA) administered orally every day for 3 months<br>* Other names: eicosapentaenoic acid/docosahexaenoic acid;|
| Placebo Comparator: 2<br> | Dietary Supplement: placebo<br>* placebo administered orally every day for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammation, end stage renal disease