Very Low Protein Diet and Renal Death in Chronic Kidney Disease (CKD)-ERIKA Study
NCT ID: NCT00323713
Last Updated: 2011-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
360 participants
INTERVENTIONAL
2005-02-28
2012-12-31
Brief Summary
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Detailed Description
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The improvement in the management of metabolic and cardiovascular complication associated to chronic kidney disease (CKD) since the early stages of the disease becomes mandatory in order to delay the start of dialysis and to ameliorate the whole patient outcome.
Dietary protein restriction represents a basic therapeutic approach in CKD, by reducing the accumulation of nitrogen catabolic substances, the phosphorus retention and the consequent hyperparathyroidism, the metabolic acidosis, the salt intake and the consequent hypertension, the proteinuria, and by improving the anemia and the glycemic tolerance, but the effects of the low protein diet on renal failure progression rate have not been definitely demonstrated.
Dietary effective reduction of just 0.2 g/kg/day of proteins is effective in ameliorating blood urea nitrogen, metabolic acidosis and hyperphosphoremia, and the very low protein diet (VLPD) allows a further improving of the metabolic control of uremia, it is safe, not affecting the nutritional status, and it is cost saving. VLPD has been suggested to delay the start of renal replacement therapy with respect to standard low protein diet, by mean of either secondary analysis of clinical trials or retrospective analysis.
Large randomized clinical trials (RCT) on this issue lack, and the effect of VLPD on renal death remain to be addressed. As well, information on patients' compliance to VLPD prescription and on the impact of VLPD on the quality of life are needed. Finally, also the effects of VLPD on both cardiovascular risk factors and mortality remain to be completely evaluated.
The primary aim of this study is to evaluate, by mean of a RCT, the effect of the very low protein diet on the renal death in renal patients affected by chronic renal insufficiency of moderate to advanced degree (CKD stages 4 and 5). Secondary aims are to evaluate the effect of VLPD on cardiovascular risk factors, morbidity and mortality, the adherence to VLPD, and the relationship between VLPD and quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VLPD diet
Adavnced CKD patients (stage 4-5) on a very low protein diet
Very low protein diet
0.3 g of proteins per kilo of body weight per day, supplemented with a mixture of essential aminoacids and chetoacids
LPD diet
Adavnced CKD patients (stage 4-5) on a low protein diet
Low protein diet
0.6 g of protein per kilo of body weight per day
Interventions
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Very low protein diet
0.3 g of proteins per kilo of body weight per day, supplemented with a mixture of essential aminoacids and chetoacids
Low protein diet
0.6 g of protein per kilo of body weight per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Incident patients with chronic renal insufficiency in stage CKD 4 and 5 (GFR \< 30 ml/min/1.73m2, estimated by the 24-hours creatinine clearance), provided stable renal function determined by two 24-hour measurements of creatinine clearance 2 weeks a part
Exclusion Criteria
* Change of creatinine clearance \> 30% within the last 3 months
* Severe undernutrition as indicated by :
1. BMI \< 20 kg/m2 in presence of serum albumin \< 3.0 g/dl, or BMI \< 17.5 kg/m2 whatever albumin value
2. body weight reduction \> 7.5% within the last 3 months
* Severe obesity as indicated by BMI \> 35 kg/m2
* Pregnancy or feeding
* Chronic treatment with steroid or cytotoxic drugs
* Fast progressing glomerulonephritis
* Active SLE and vasculitis
* Cardiac failure stage IV NYHA
* Advanced liver cirrhosis
* Active cancer diseases
* Severe encephalopathy associated with lack of spontaneous feeding
* Chronic obstructive respiratory diseases needing oxygen treatment
18 Years
ALL
No
Sponsors
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Azienda Sanitaria ASL Avellino 2
OTHER
Responsible Party
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ASL_AV 2 - Avellino - Italy
Principal Investigators
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Vincenzo Bellizzi, MD, PhD
Role: STUDY_CHAIR
Nephrology Unit "A. Landolfi" Hospital, Solofra (AV) Italy
Giuseppe Conte, MD
Role: STUDY_CHAIR
Division of Nephrology, Medical School, Second University of Naples, Naples, Italy
Ciro Gallo, MD
Role: STUDY_CHAIR
Biostatistics Unit, Medical School, Second University of Naples, Naples, Italy
Locations
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Nephrology Unit, "Moscati" Hospital
Avellino, AV, Italy
Nephrology Unit, S. Angelo dei Lombardi Hospital
Sant'Angelo dei Lombardi, AV, Italy
Nephrology Unit "A. Landolfi" Hospital
Solofra, AV, Italy
Nephrology Division, Medical School, University of Bari
Bari, BA, Italy
Nephrology Unit, Brindisi Hospital
Brindisi, BR, Italy
Nephrology Unit, Piedimonte Matese Hospital
Piedimonte Matese, CE, Italy
Nephrology Unit, S. Felice a Cancello Hospital
San Felice A Cancello, CE, Italy
Nephrology Division, Medical School, University of Catanzaro
Catanzaro, CZ, Italy
Nephrology Division, Medical School, University of Foggia
Foggia, FG, Italy
Nephrology Unit, Foggia Hospital
Foggia, FG, Italy
Nephrology Unit, San Severo Hospital
San Severo, FG, Italy
Nephrology Unit, Galatina Hospital
Galatina, LE, Italy
Nephrology Division, "San Carlo" Hospital
Potenza, PZ, Italy
Nephrology Unit, "Curto" Hospital
Polla, SA, Italy
Nephrology Unit, Castellammare Hospital
Castellammare di Stabia, , Italy
Nephrology Division, Medical School, University "Federico II" of Naples
Napoli, , Italy
Nephrology Division, Medical School, Second University of Naples
Napoli, , Italy
Countries
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References
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Di Iorio BR, Minutolo R, De Nicola L, Bellizzi V, Catapano F, Iodice C, Rubino R, Conte G. Supplemented very low protein diet ameliorates responsiveness to erythropoietin in chronic renal failure. Kidney Int. 2003 Nov;64(5):1822-8. doi: 10.1046/j.1523-1755.2003.00282.x.
Di Iorio BR, Bellizzi V, Minutolo R, De Nicola L, Iodice C, Conte G. Supplemented very low-protein diet in advanced CRF: is it money saving? Kidney Int. 2004 Feb;65(2):742. doi: 10.1111/j.1523-1755.2004.404_2.x. No abstract available.
Bellizzi V, Di Iorio BR, De Nicola L, Minutolo R, Zamboli P, Trucillo P, Catapano F, Cristofano C, Scalfi L, Conte G; ERIKA Study-group. Very low protein diet supplemented with ketoanalogs improves blood pressure control in chronic kidney disease. Kidney Int. 2007 Feb;71(3):245-51. doi: 10.1038/sj.ki.5001955. Epub 2006 Oct 11.
Hahn D, Hodson EM, Fouque D. Low protein diets for non-diabetic adults with chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 29;10(10):CD001892. doi: 10.1002/14651858.CD001892.pub5.
Other Identifiers
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KA1-1425
Identifier Type: -
Identifier Source: org_study_id
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