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

April 24, 2008 updated by: Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
low protein diet
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
Other Names:
  • LP
  • HP
  • sLP
Active Comparator: 2
low protein diet with keto acids
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
Other Names:
  • LP
  • HP
  • sLP
Active Comparator: 3
high protein diet
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
Other Names:
  • LP
  • HP
  • sLP

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Yao Qiang, MD, Ph.D, RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 12, 2008

Study Record Updates

Last Update Posted (Estimate)

April 28, 2008

Last Update Submitted That Met QC Criteria

April 24, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05PJ14057(Shanghai, China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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