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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633646
• Other study ID #: 05PJ14057(Shanghai, China)
• Status: Completed
• Phase: N/A
• First received: February 22, 2008
• Last updated: April 24, 2008
• Start date: January 2006
• Est. completion date: February 2008

Study information

• Verified date: March 2008
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Peritoneal Dialysis
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• diets contained different levels of protein
diets contain protein in the range of 0.6-0.8 or 1.0-1.2 g/kg/d

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nitrogen balance,residual renal function and nutritional status		10 day and 1 year	Yes