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

Sponsored by:	Shanghai Jiao Tong University of Medicine
Information provided by:	Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:	NCT00633646

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:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in PD Patients

Resource links provided by NLM:

MedlinePlus related topics: Diets Kidney Failure

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
1: Active Comparator 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
2: Active Comparator 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
3: Active Comparator 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

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 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:	Renji Hospital, Shanghai Jiaotong University, School of Medicine ( Qiang Yao )
Study ID Numbers:	05PJ14057(Shanghai, China)
Study First Received:	February 22, 2008
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00633646 History of Changes
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

Study placed in the following topic categories:

Renal Insufficiency
Malnutrition
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 10, 2009