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

NCT ID: NCT00633646

Last Updated: 2008-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease Peritoneal Dialysis

Keywords

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nitrogen balance malnutrition chronic kidney disease diet glomerular filtration rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

low protein diet

Group Type ACTIVE_COMPARATOR

diets contained different levels of protein

Intervention Type DIETARY_SUPPLEMENT

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

2

low protein diet with keto acids

Group Type ACTIVE_COMPARATOR

diets contained different levels of protein

Intervention Type DIETARY_SUPPLEMENT

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

3

high protein diet

Group Type ACTIVE_COMPARATOR

diets contained different levels of protein

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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LP sLP HP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Renji Hospital, Shanghai Jiaotong University, School of Medicine

Principal Investigators

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Yao Qiang, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Other Identifiers

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05PJ14057(Shanghai, China)

Identifier Type: -

Identifier Source: org_study_id