Chronic Kidney Disease Clinical Trial
Official title:
Effects of Low Protein Diet Supplemented Keto-/Amino Acid in Preventing the Progression of Chronic Kidney Disease(CKD)- ELPD Study
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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