A Randomized Controlled Trial to Assess the Effects of Oral Alkali Therapy in Patients with Diabetic Kidney Disease

Abstract

Background: To analyze the effects of oral alkali therapy on renal function, nutritional status and bone density in patients of diabetic kidney disease. Material & Methods: A randomized controlled trial was conducted on 60 patients of age>18 years with diabetic kidney disease who were not on dialysis and had plasma bicarbonate levels between 16 and 20 mmol/l. Patients were randomly divided into two groups: Test group (n=30) which received oral alkali therapy as sodium bicarbonate and control group (n=30) who did not receive oral alkali therapy. The patients were followed for 12 months to compare the improvement. Results: In comparison to controls, test group showed a significant improvement in the Hb (0.7 vs. 0.25, P =0.003), significantly less decrease in eGFR (-2.25 vs. -2.9, P=0.049), non-significant less increase in creatinine (-0.26 ± 0.4 vs. -0.43 ± 0.33, P=0.09), significant improvement in bicarbonate levels (7.5 vs. 1, p<0.0001), significant restoration of albumin (0.32 vs. 0.05, P<.0001), significant fall in iPTH levels (50 vs. 25, p=0.007) and ALP levels (32 vs. 12, p=0.015). Bone density (0.28 ± 0.17 vs. 0.01 ± 0.13, P<.0001) and clinical well-being VAS scores improved significantly among the cases (9.83 ± 5.65 vs. -1.67 ± 7.11, P<.0001). Conclusion: In conclusion, oral alkali therapy slows the rate of decline of renal function and the development of end stage renal disease in patients with advanced stages of CKD. This cheap and simple strategy, which is in line with current renal consensus documents, also improves the nutritional status of patients and bone density.