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Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease (CKD)- ELPD Study (ELPD-CKD)

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ClinicalTrials.gov Identifier: NCT01418508
Recruitment Status : Unknown
Verified August 2011 by gwcmc.
Recruitment status was:  Recruiting
First Posted : August 17, 2011
Last Update Posted : August 17, 2011
Sponsor:
Information provided by:
gwcmc

August 15, 2011
August 17, 2011
August 17, 2011
August 2011
December 2014   (Final data collection date for primary outcome measure)
changes in glomerular filtration rate [ Time Frame: 1 year ]
Same as current
No Changes Posted
  • Compliance to diet [ Time Frame: 1 year ]
  • Quality of life [ Time Frame: 1 year ]
  • Cardiovascular morbidity [ Time Frame: 1 year ]
    Cardiovascular morbidity, defined by angina, heart failure, myocardial infarction, left ventricular mass, stroke, blood pressure, lipid profile, calcium/phosphorus/parathormone status and Charlson comorbidity index, at the start of dialysis
  • Nutritional status [ Time Frame: 1 year ]
    Nutritional status, defined by anthropo-plicometry, biochemistry, body bioimpedance analysis (BIA), subjective global nutritional assessment (SGA), at the start and during the 1st year of dialysis
Same as current
Not Provided
Not Provided
 
Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease (CKD)- ELPD Study
Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)- ELPD Study
The purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (CKD , stage 3b and 4).

Dietary protein restriction represents a basic therapeutic approach in chronic kidney disease(CKD), by reducing the accumulation of nitrogen catabolic substances, and by delaying the progress of CKD and proteinuria, but the effects of the different degree's protein diet on the renal progression remain to be determined.

The aim of this study is to evaluate the efficacy of low protein diet and α-keto acid tablet in retard the progress of CKD. This is a randomized, open-label, prospective study, 120 patients who meet inclusion and exclusion criteria will be randomized into three groups at the ratio of 1:1:1. Group I patients will receive low protein diet(0.6g/kg BW), group II will receive low protein diet supplemented with α-keto acid, while group III will take very low protein diet(0.3g/kg BW) supplemented with α-keto acid. The changes of glomerular filtration rate in CKD will be evaluated after 1 year treatment.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Kidney Disease
  • Behavioral: low protein diet plus α-keto acid
    low protein diet plus α-keto acid 0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets
  • Behavioral: very low protein diet plus α-keto acid
    very low protein diet plus α-keto acid 0.3g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets
  • No Intervention: low protein diet
    Behavioral: low protein diet 0.6g of proteins per kilo of body weight per day
  • Experimental: low protein diet plusα-keto acid
    0.6g of proteins per kilo of body weight per day
    Intervention: Behavioral: low protein diet plus α-keto acid
  • Experimental: very low protein diet plus α-keto acid
    0.3g of proteins per kilo of body weight per day
    Intervention: Behavioral: very low protein diet plus α-keto acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
Same as current
December 2014
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with chronic kidney disease in stage 3b and 4(15ml/min/1.73m2<GFR<45 ml/min/1.73m2, estimated by EPI formula) receiving conservative treatment for CKD

Exclusion Criteria:

  • With diagnosis of diabetic mellitus;
  • Incapable of following study requirements to control diet;
  • Glomerular filtration rate < 15 ml/min/1.73m2;
  • Hypercalcemia or hyperkalemia (> normal upper limit);
  • Other serious disease(eg.heart,lung,brain) within the last 3 months;
  • Cardiac failure stage IV NYHA;
  • With cirrhosis of liver or obvious symptoms of liver diseases, ALT or AST two times normal upper limit;
  • Severe edema or serous cavity effusion;
  • Drug abuse;
  • Final diagnosis of malignant tumor;
  • Receiving the long-term systematic steroid hormone or immunosuppressive agents(eg. Cyclophosphamidum,Cyclosporine, Prograf,Azathioprine) treatment;
  • Gestation already, prepares to be pregnant in the period of the trial, lactating women;
  • Participate in other product clinical trial within 30 days prior to this trial
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01418508
ELPD-CKD
Yes
Not Provided
Not Provided
Xuemei Li, department of nephrology
gwcmc
Not Provided
Principal Investigator: Xuemei Li, M.D.& Ph.D. gwcmc
gwcmc
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP