Chronic Kidney Disease Clinical Trial
Official title:
Comparison of the Effects Between Keto-/Amino Acid Supplemented Low Protein Diet and Non-Supplemented Low Protein Diet in Patients With Stage Ⅴ Chronic Kidney Disease
Keto-/amino acid supplemented low protein diet can reduce uremic symptoms, improve nutritional status, delay dialysis therapy and enhance health-related quality of life in our patients with stage V CKD in comparison to non-supplemented low protein diet.
Fifty patients will be included into the study. The study comprises 9 visits. The treatment
period covers 6 months, preceded by a 2-week screening period and a 1 month run-in period.
Patients are required to visit the investigator two times before the start of active
treatment.
All patients who are qualified for this study will then be randomised by receiving their
medication/introduction of dietary management using the standard simple randomization
method.Group I patients will receive keto-/amino acid (Ketosteril) supplemented low protein
diet during the active treatment period while Group II patients will receive
non-supplemented low protein diet during the same period. The daily dose of keto-/amino acid
for each Group I patient is one tablet every 5 kg body weight. The total daily dose will be
divided into three times a day.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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