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

Chronic Kidney Disease Clinical Trial

— ELPD-CKD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01418508
• Other study ID #: ELPD-CKD
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2011
• Last updated: August 16, 2011
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: August 2011
• Source: Peking Union Medical College Hospital
• Contact: Xuemei Li, M.D.& Ph.D.
• Phone: 8610-65295058
• Email: 0605.mei[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• low protein diet plus a-keto acid
low protein diet plus a-keto acid 0.6g of proteins per kilo of body weight per day, supplemented with a-keto acid tablets
• very low protein diet plus a-keto acid
very low protein diet plus a-keto acid 0.3g of proteins per kilo of body weight per day, supplemented with a-keto acid tablets

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in glomerular filtration rate		1 year	Yes
Secondary	Compliance to diet		1 year	No
Secondary	Quality of life		1 year	No
Secondary	Cardiovascular morbidity	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	1 year	Yes
Secondary	Nutritional status	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	1 year	Yes