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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418508
First Posted: August 17, 2011
Last Update Posted: August 17, 2011
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:
Peking Union Medical College Hospital
  Purpose
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).

Condition Intervention
Chronic Kidney Disease Behavioral: low protein diet plus α-keto acid Behavioral: very low protein diet plus α-keto acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)- ELPD Study

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • changes in glomerular filtration rate [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Experimental: very low protein diet plus α-keto acid
0.3g of proteins per kilo of body weight per day
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01418508


Contacts
Contact: Xuemei Li, M.D.& Ph.D. 8610-65295058 0605.mei@gmail.com
Contact: Limeng Chen, M.D.& Ph.D. 8610-65295351 climeng2000@yahoo.com.cn

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Xuemei Li, M.D.& Ph.D.    8610-65295058    0605.mei@gmail.com   
Contact: Limeng Chen, M.D.& Ph.D.    8610-65295351    climeng2000@yahoo.com.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Xuemei Li, M.D.& Ph.D. Peking Union Medical College Hospital
  More Information

Responsible Party: Xuemei Li, department of nephrology
ClinicalTrials.gov Identifier: NCT01418508     History of Changes
Other Study ID Numbers: ELPD-CKD
First Submitted: August 15, 2011
First Posted: August 17, 2011
Last Update Posted: August 17, 2011
Last Verified: August 2011

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