Supplemented Very Low Protein Diet and the Progression of Chronic Kidney Disease (KETOPROG)
|Chronic Kidney Disease||Behavioral: Conventional low protein diet Dietary Supplement: Very low protein diet supplemented with Ketosteril||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
|Official Title:||Effect of Very Low Protein Diet Supplemented With Ketoanalogues of the Essential Amino Acids on the Progression of Chronic Kidney Disease|
- Primary composite endpoint [ Time Frame: 15 months after randomization ]Need for renal replacement therapy or an at least 50% reduction in the estimated glomerular filtration rate compared to randomization
- Secondary efficacy parameter [ Time Frame: months 3-15 after randomization ]The rate of decline in the estimated Glomerular Filtration Rate
- Secondary outcome measure - nitrogen balance [ Time Frame: 15 months after randomization ]variations in serum urea
- Secondary efficacy parameter - mineral metabolism [ Time Frame: 15 weeks after randomization ]variations in total serum calcium
- Secondary efficacy parameter [ Time Frame: 15 weeks after randomization ]variations in serum phosphate level
- Secondary efficacy parameter [ Time Frame: 15 weeks after randomization ]variations in serum bicarbonate
- Secondary safety parameter [ Time Frame: 18 weeks after enrolment ]Subjective Global Assessment of the nutritional status
- Secondary safety parameter [ Time Frame: 18 weeks after enrolment ]Body Mass Index
- Secondary outcome measure - Nutritional status [ Time Frame: 18 weeks after enrolment ]Tricipital skinfold
- Secondary safety parameter - anthropometric measures [ Time Frame: 18 weeks after enrolment ]Mid-arm muscular circumference
- Nutritional status - biochemical markers [ Time Frame: 18 weeks after enrolment ]serum albumin
- Inflammation [ Time Frame: 18 weeks after enrolment ]serum level of C reactive protein
- Nutritional status - biochemical marker [ Time Frame: 18 weeks after enrolment ]Serum total cholesterol
- Secondary safety parameter [ Time Frame: 18 weeks after enrolment ]Serum potassium level
- Secondary safety parameter [ Time Frame: 18 weeks after enrolment ]liver enzymes: Aspartate Aminotransferase, Alanine Transaminase
- Safety parameter - adverse events [ Time Frame: 18 weeks after enrolment ]Occurrence of any adverse event
- Secondary safety parameter - withdrawals [ Time Frame: 18 weeks after enrolment ]number of withdrawals
- Compliance - protein intake [ Time Frame: 18 months after enrolment ]urinary urea nitrogen excretion to calculate the protein intake
- Compliance - energy intake [ Time Frame: 18 weeks after enrolment ]3-day food diary to calculate the daily energy intake
|Study Start Date:||March 2008|
|Study Completion Date:||August 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Keto-diet (KD)
Patients in the intervention arm (KD group) will receive a vegetarian very low protein diet (0.3 g proteins/kg ideal body weight per day) supplemented with ketoanalogues of essential amino acids (Ketosteril®, Fresenius Kabi, Bad Homburg, Germany), 1 capsule for every 5 kg of ideal dry body weight per day.
Dietary Supplement: Very low protein diet supplemented with Ketosteril
Other Name: SVLPD, Keto-diet
Active Comparator: Low Protein Diet group (LPD)
The patients in the control arm (LPD group) will continue their conventional low protein diet, with 0.6 g/kg per day (including high biological value proteins).
The total recommended energy intake is of 30 kcal/kg of ideal dry body weight per day in both arms.
Behavioral: Conventional low protein diet
All eligible patients who will give informed consent will be screened. Those meeting the selection criteria will be enrolled and will enter a 3-month run-in phase during which a conventional LPD will be prescribed in all patients.
At the end of this phase, the subjects still fulfilling all the selection criteria will be randomized in a 1:1 ratio to receive the KD or to continue the conventional LPD for a total duration of 15 months.
Nineteen blood and urine samplings are scheduled for each patient, to be drawn monthly. The laboratory reports include the nitrogen compounds, calcium-phosphorus metabolism parameters, acid-base balance, biochemical nutritional markers, serum C-reactive protein, hemoglobin, blood cell count, and biochemical safety parameters (sodium, potassium, liver enzymes, and bilirubin).
The anthropometric measurements and subjective global assessment will be evaluated at enrolment, at randomization, and every 3 months thereafter.
The compliance with the prescribed diet (protein and energy intake) will be assessed monthly during the run-in phase, weekly for the first month after randomization, every 4 weeks during the next 6 months, and every 3 months thereafter.
The blood pressure levels, drugs required for the therapy of hypertension, acidosis and mineral metabolism disorders, and occurrence of adverse events will be recorded monthly.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02031224
|"Dr Carol Davila" Teaching Hospital of Nephrology|
|Bucharest, Romania, 010731|