SP405RANDOMIZED, CONTROLLED STUDY ON SUPPLEMENTATION OF KETOANALOGUES IN PREDIALYSIS PATIENTS TO PREVENT DECLINE IN GLOMERULAR FILTRATION RATE (GFR)

Abstract

INTRODUCTION AND AIMS: In chronic kidney disease (CKD) dietary protein restriction can prevent functional deterioration through reduction in glomerular capillary pressure and filtration. OBJECTIVE: To establish if ketoanalogue supplementation combined with low protein diet retards progression of CKD based on GFR. METHODS: Forty (40) CKD patients were randomized into two groups: group 1 was supplemented (n=9) with ketoanalogues tablets for six /day for 10 months with very low protein diet 0.4 g/kg/day. Patients were not kept on 0.3g/kg/d protein as full dose of ketoanalogues (as recommended by MDRD study) was not given due to pill burden. Group 2 (n=20 control) patients were given conservative treatment with 0.6 g/kg/d protein restriction without supplementation. Patients were counselled on low protein and very low protein intake at the begining of the study. Study was approved by institute's ethics committee. GFR and serum albumin were evaluated at baseline and at 10 months. RESULTS: At baseline, the GFR was higher in controls (51.14±15.1 ml/minute) compared to supplemented group (47.79±13.2 ml/minute). Over a period of 10 months the GFR declined in the control group from 51.14 ml/min at baseline to 35.5±7.94 ml/minute at 10 months. In the supplemented group the GFR declined from, 47.79±13.2 to 43.90±15.82 ml/minute. The serum albumin level decreased from 3.8±0.90 g/dL to 3.09±0.38 g d/l in control group, while the levels were maintained in supplemented group. There was significant difference in the serum albumin levels at 10 months between intervention (4.03±0.52 g/dL) and control (3.09±0.38 g/dL) group . Despite nutritional counselling, there was non compliance to dietary protein restriction in both the groups (group 1 protein intake 0.72±0.35 g/kg/d and group 2 protein intake 0.8±6 0.26 g/kg/d). In ketoanalogue group decline in GFR was 3.5 ml/min in 10 months while in the control group decline in GFR was 16 ml/minute in 10 months. However, the serum albumin was maintained in supplemented group apparently because of Ketoanalogue supplementation and normal protein diet. CONCLUSIONS: Adherence to very low protein diet is fundamental to ketoanalogue supplementation for retarding progression of kidney disease, but to achieve this strict adherence to low protein diet is essential with focused counselling. Serum albumin was maintained in supplemented group, apparently because of ketoanalogue supplementation and normal protein intake (0.7g/kg/d instead of 0.4g/kg/d), This needs to be explored with more studies if ketoanalogue can be given to predialysis patients with 0.6 g/kg/d protein in order to prevent or mitigate malnutrition in malnourished CKD patients.