Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00633646
First received: February 22, 2008
Last updated: April 24, 2008
Last verified: March 2008
History of Changes
  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: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633646

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

No publications provided

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)
Study First Received: February 22, 2008
Last Updated: April 24, 2008
Health Authority: China: Ministry of Health

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
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013