Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients
|ClinicalTrials.gov Identifier: NCT00734552|
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : May 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Dialysis||Dietary Supplement: α-Keto Acid with low protein diet Dietary Supplement: Normal protein diet||Not Applicable|
Residual renal function (RRF) is associated with cardiovascular complication, nutritional status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients. Therefore, RRF is an important determinant of mortality and morbidity in PD patients.
Previous studies have suggested that dietary protein restriction supplemented with compound keto/amino acids may slow the loss of RRF in chronic kidney disease patients. However, there is very few reports to address the effect of compound keto/amino acid supplementation in RRF in PD patients.
The aim of this study is to evaluate the protective effect of compound α-Keto Acid plus low protein diet in RRF in PD Patients.This is a randomized, open-label, prospective study. 100 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. α-Keto Acid group will use compound α-Keto Acid plus low protein diet, while control group will use normal protein diet.Compound α-Keto Acid dosage is 0.1/kg/d daily. The effect of compound α-Keto Acid plus low protein diet in RRF will be evaluated after 1 year treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Open-Label, Prospective Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Residual Renal Function (RRF) in Peritoneal Dialysis Patients|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||May 2010|
Active Comparator: 1
α-Keto Acid plus low protein diet
Dietary Supplement: α-Keto Acid with low protein diet
Compound α-Keto Acid: The daily dose of compound α-Keto Acid is 0.1/kg/d. The total daily dose will be divided into three times a day.
Low Protein Diet: Diet contain protein 0.8g/kg/d.
Other Name: Test Group
Normal protein diet
Dietary Supplement: Normal protein diet
Diet contain protein 1.0-1.2 g/kg/d.
Other Name: Control Group
- The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume [ Time Frame: Every 3 months ]
- Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects. [ Time Frame: Every 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734552
|The 1st Affiliated Hospital, Sun Yet-sen University|
|GuangZhou, Guangdong, China, 510080|
|Principal Investigator:||Xueqing Yu, M.D. & Ph.D.||1st Affiliated Hospital, Sun Yat-Sen University|