MO032AN OPEN LABEL RANDOMIZED CLINICAL STUDY TO EVALUATE THE IMPACT OF PROTEIN SUPPLEMENT ON SERUM ALBUMIN IN PATIENTS ON MAINTENANCE DIALYSIS (IMPROVES STUDY)

Abstract

INTRODUCTION AND AIMS: Protein energy wasting affects morbidity and survival of patients on maintenance dialysis. Aim of the study was to evaluate effect of renal specific protein supplement on hypoalbuminemia in patients on maintenance dialysis over a period of 6 months. METHODS: Multicentric oral nutritional intervention study on maintenance dialysis patients with hypoalbuminemia (serum albumin <3.8g/100mL) and PEW as per ISRNM criteria was approved by ethics committee. 180 patients (90 supplemented and 90 control) were randomly assigned to standard treatment 1.2g/kg/d protein and 35 kcal/kg/d(control) or standard treatment plus protein supplement daily in three divided doses (supplemented) for 6 months. Renal specific protein powder supplement contained 70% soya protein. Patients were evaluated on 3 visits at months 0, 3 and 6. At each visit, nutritional status was assessed by SGA, 24 hour dietary recall, dietary diaries and anthropometry, routine biochemical parameters. RESULTS: At inclusion, no difference in age, sex, SGA and routine biochemistry was observed. Control group, however, had significantly higher serum albumin (3.37±0.36 vs. 3.2±0.41 g/dL; p 0.013) and subscapular skinfold thickness (1466.0 vs. 12.1 65.0 mm; p 0.032) than supplemented group. Compliance was assessed by counting empty tins returned by the patient. At visit 1, 2 and 3 there was significant difference in protein intake in supplemented and control groups (48.35±14.2 and 51.93±16.4; 65.15±21.86 and 63.49±19.4; and 67.05±20.7 and 65.36±19.1 g/day respectively). At visit 1, 2 and 3 in supplemented and control groups there was significant difference in energy intake (1546.06±397.24 and 1607.416396; 1774.73±535.9 and 1730.496 408.15; and 1891.316 490.6 and 1813.26±464.82 kcals/day). At month 3, the serum albumin (3.4 60.43 vs. 3.3 60.48 g/dL) and illiac SFT (18.1 ± 8.6 vs.15.5 68.5 mm; p 0.043), increased significantly in the supplemented group. At six months in supplemented group serum albumin increased significantly (p= 0.000) to 3.96 0.49 versus 3.3 60.51 in control group (Figure 1). Nutritional status as per SGA score improved in supplemented compared. At 6 months the biceps (13.0±7.1 vs 9.1±6.0 mm), triceps (16.1±5.1 vs 12.1±5.1 mm), subscapular (17.0±7.2 vs. 16.46±.9 mm) and suprailliac SF (18.1±8.7 vs 16.8±8.7 mm) were significantly higher in supplemented group (p 0.000) compared to controls. CONCLUSIONS: Addition of protein‐rich renal specific nutritional supplement to standard nutritional counseling raised serum albumin and increased skinfold thickness in PEW patients undergoing dialysis. (Figure Presented).