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

Primary Purpose

Chronic Kidney Disease, Peritoneal Dialysis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

diets contained different levels of protein

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring nitrogen balance, malnutrition, chronic kidney disease, diet, glomerular filtration rate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

low protein diet

low protein diet with keto acids

high protein diet

Outcomes

Primary Outcome Measures

nitrogen balance,residual renal function and nutritional status

Secondary Outcome Measures

Full Information

NCT ID

NCT00633646

First Posted

February 22, 2008

Last Updated

April 24, 2008

Sponsor

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00633646

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease, Peritoneal Dialysis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

low protein diet

Arm Title

Arm Type

Active Comparator

Arm Description

low protein diet with keto acids

Arm Title

Arm Type

Active Comparator

Arm Description

high protein diet

Intervention Type

Dietary Supplement

Intervention Name(s)

diets contained different levels of protein

Other Intervention Name(s)

LP, sLP, HP

Intervention Description

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

Primary Outcome Measure Information:

Title

nitrogen balance,residual renal function and nutritional status

Time Frame

10 day and 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yao Qiang, MD, Ph.D

Organizational Affiliation

RenJi Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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