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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00633646
First Posted: March 12, 2008
Last Update Posted: April 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shanghai Jiao Tong University School of Medicine
  Purpose
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.

Condition Intervention
Chronic Kidney Disease Peritoneal Dialysis Dietary Supplement: diets contained different levels of protein

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in PD Patients

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • nitrogen balance,residual renal function and nutritional status [ Time Frame: 10 day and 1 year ]

Enrollment: 94
Study Start Date: January 2006
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • sLP
  • HP
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
  • sLP
  • HP
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
  • sLP
  • HP

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633646


Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Yao Qiang, MD, Ph.D RenJi Hospital
  More Information

Responsible Party: Qiang Yao, Renji Hospital, Shanghai Jiaotong University, School of Medicine
ClinicalTrials.gov Identifier: NCT00633646     History of Changes
Other Study ID Numbers: 05PJ14057(Shanghai, China)
First Submitted: February 22, 2008
First Posted: March 12, 2008
Last Update Posted: April 28, 2008
Last Verified: March 2008

Keywords provided by Shanghai Jiao Tong University School of Medicine:
nitrogen balance
malnutrition
chronic kidney disease
diet
glomerular filtration rate

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency