Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in Peritoneal Dialysis (PD) Patients

Study Overview
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Brief Summary
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Current therapy recommendations suggest a low protein diet to preserve residual renal function (RRF) before the start of dialysis, but a higher protein intake during dialysis to prevent protein-energy wasting (PEW). We conducted a randomized trial to test whether low protein intake also during treatment with peritoneal dialysis (PD) would be safe and associated with a preserved RRF.

Detailed Description
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Dietary protein is the major source of nitrogen excreted as urea by the kidney, and a decreased protein intake has been associated with a retardation of kidney function loss in non-dialysis chronic kidney disease (CKD) patients. While a low protein diet is recommended to end-stage renal disease (ESRD) patients before the start of dialysis to preserve residual renal function(RRF), current therapy recommendations in dialysis are for a normal protein intake of no less than 1.2 g of protein/kg ideal body weight (IBW)/day to prevent protein-energy wasting (PEW). We hypothesized that a lower protein intake would be safe and able to slow the loss of RRF also in dialysis patients and conducted two prospective, randomized trials involving a total of 94 peritoneal dialysis (PD) patients to test our hypothesis.

Official Title
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Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in PD Patients

Conditions
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Chronic Kidney Disease, Peritoneal Dialysis

Intervention / Treatment
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* Dietary Supplement: diets contained different levels of protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-80 years stable peritoneal dialysis since at least 1 month with renal function Exclusion Criteria: a high probability (assessed by the recruiting physician) of receiving a kidney transplant within one year overt infection within the last month poor compliance in previous dietary prescriptions or irregular check-ups persistent anorexia, vomiting or diarrhea within the last month a CRP of more than 30 mg/dL presence of wasting diseases such as cancer or tuberculosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>low protein diet | Dietary Supplement: diets contained different levels of protein<br>* diets contain protein in the range of 0.6-0.8 or 1.0-1.2 g/kg/d<br>* Other names: HP;|
| Active Comparator: 2<br>low protein diet with keto acids | Dietary Supplement: diets contained different levels of protein<br>* diets contain protein in the range of 0.6-0.8 or 1.0-1.2 g/kg/d<br>* Other names: HP;|
| Active Comparator: 3<br>high protein diet | Dietary Supplement: diets contained different levels of protein<br>* diets contain protein in the range of 0.6-0.8 or 1.0-1.2 g/kg/d<br>* Other names: HP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nitrogen balance,residual renal function and nutritional status |  | 10 day and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nitrogen balance, malnutrition, chronic kidney disease, diet, glomerular filtration rate