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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00633646
Enrollment
94
Registered
2008-03-12
Start date
2006-01-31
Completion date
2008-02-29
Last updated
2008-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Peritoneal Dialysis

Keywords

nitrogen balance, malnutrition, chronic kidney disease, diet, glomerular filtration rate

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.

Interventions

DIETARY_SUPPLEMENTdiets contained different levels of protein

diets contain protein in the range of 0.6-0.8 or 1.0-1.2 g/kg/d

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
nitrogen balance,residual renal function and nutritional status10 day and 1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026