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

Not Applicable
Completed
Conditions
Chronic Kidney Disease
Peritoneal Dialysis
Interventions
Dietary Supplement: diets contained different levels of protein
Registration Number
NCT00633646
Lead Sponsor
Shanghai Jiao Tong University School of Medicine
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
94
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1diets contained different levels of proteinlow protein diet
2diets contained different levels of proteinlow protein diet with keto acids
3diets contained different levels of proteinhigh protein diet
Primary Outcome Measures
NameTimeMethod
nitrogen balance,residual renal function and nutritional status10 day and 1 year
Secondary Outcome Measures
NameTimeMethod
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