Protein, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease
Completed
Conditions studied: End Stage Renal Disease
In brief
National Kidney Foundation guidelines recommend a dietary protein intake of 1.2 grams per kilogram per day (g/kg/d) in hemodialysis patients. However, it is unclear whether consumption of high amounts of protein in dialysis patients has beneficial or harmful nutritional and cardiovascular effects in this population. High protein intake might improve nutritional status, but it has been argued that the state of low muscle mass, small body size and low serum protein levels is not the result of decreased dietary intake, rather a result of hypercatabolism induced by metabolic acidosis, inflammation and oxidative stress. The specific aims of this study are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake or dietary protein intake with muscle mass and arterial stiffness.
Key facts
- Study ID
- NCT00566670
- Run by
- University of Utah
- People needed
- 145
- Starts
- 2007-09-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2016-08-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult stage 5 chronic kidney disease patients, on dialysis for at least 3 months.
- Urine output > 200 mL/day
You may not qualify if…
- Patients with persistent volume overload (substantial pedal edema) despite attempts at achieving dry weight
- Patients with inability to walk or who use a wheel-chair with reduced mid-thigh muscle mass
- Persons with pacemakers, cochlear implants, or other prohibitive conditions for magnetic resonance imaging
- Atrial fibrillation
- Patients who are unlikely or unable (in the opinion of the nephrologists, nurses or dieticians taking care of the patient) to comply with research protocol
- Patients with symptomatic heart failure, current active malignancy (excluding squamous and basal cell skin cancers), active AIDS, chronic lung disease requiring supplemental oxygen therapy and cirrhosis
- Patients enrolled in interventional trials
Where it is running
- Vanderbilt University Medical Centet — Nashville, Tennessee, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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