End Stage Renal Disease
Conditions
Keywords
inflammation, end stage renal disease
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.
Interventions
DIETARY_SUPPLEMENTfish oil
2.9 g of fish oil (2:1 EPA:DHA) administered orally every day for 3 months
DIETARY_SUPPLEMENTplacebo
placebo administered orally every day for 3 months
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed