Effect of oral calcitriol pulse therapy on the lipid, calcium, and glucose homeostasis of hemodialysis-patients: Its safety in a combination with oral calcium carbonate

Objective: To more clearly elucidate the conflicting results that have been obtained after oral calcitriol pulse therapy on lipid, glucose, and calcium levels in hemodialysis (HD) patients, and to determine safety of oral calcitriol pulse therapy in a combination with calcium carbonate. Design: A randomized, crossover, placebo-controlled study. Setting: HD centers in 3 teaching university hospitals. Patients: Forty-eight chronic HD patients. Methods: HD patients were randomized into 2 groups. Each group (n = 24), in addition to 4.5 g calcium carbonate daily, received either oral calcitriol pulse therapy or placebo twice weekly at the end of HD, sessions for 3 months, after which the 2 therapeutic groups were crossed-over, and for an additional 3 months, the calcitriol group received placebo, and the placebo group was put on calcitriol. Serum triglyceride, total cholesterol, low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), total calcium, alkaline phosphatase, proteins, phosphorus, parathyroid hormone (PTH), blood pH, and glucose were measured at random and at the end of 3 and 6 months of the trial. Results: After calcitriol therapy, triglyceride, serum PTH, total alkaline phosphatase, and fasting blood sugar significantly decreased, but total serum calcium significantly increased, whereas other examined parameters remained unchanged compared with the other groups. Calcium, phosphorus, calcium X phosphorus product, PTH levels, and all of these parameters were optimized in 18 (37.5%), 22 (45.8%), 34 (70.8%), 30 (62.5%), and 12 (%25) cases, respectively, in the calcitriol groups. No significant side effect was seen during the trial. Conclusion: Our findings indicate that short-term oral calcitriol pulse therapy in combination with calcium carbonate is safe and beneficial for metabolic abnormalities of HD patients; however, its safety for prolonged therapy is yet to be proved. (C) 2003 by the National Kidney Foundation, Inc.