P1413EFFECT OF PULSE ORAL VERSUS INTRAMUSCULAR VITAMIN D REPLACEMENT IN HEMODIALYSIS PATIENTS WITH VITAMIN D DEFECIENCY

Abstract Background and Aims Low 25-hydroxyvitamin D (25(OH)D) level is common in patients with chronic kidney disease and hemodialysis (HD) patients . It has been associated with high bone turnover, secondary hyperparathyroidism (SHPT), and decreased bone mineral density (BMD). We aimed to investigate the efficacy of equivalent doses of pulse oral cholecalciferol (25,000 IU weekly for 12 weeks) versus single intramuscular cholecalciferol (300,000 IU) in correcting serum 25 (OH) D levels in HD patients. Method Prospective randomized open label Clinical trial. 40 prevalent HD patients with vitamin D deficiency were enrolled. Serum 25 hydroxy-vitamin D (25 (OH) D) level < 20 ng/m and Serum parathyroid hormone level ( iPTH) >100 pg/ml. Exclusion Criteria were serum calcium > 10 .5mg/dl, Calcium phosphorus product ≥ 55, tertiary hyperparathyroidism and Parathyroidectomy among others. Patients were randomized equally into two groups. 36 patients were compliant and completed the study. Group I :17 HD patients received oral cholecalciferol 25000 IU weekly of (Vidrop® 2800 IU/ml ) for 12 weeks. Group II: 19 HD patients received a single intramuscular injection (IM) of cholecalciferol 300,000 IU (Devarol® 200000 IU/ ampoule). Vitamin D supplements were stopped if serum calcium >10.5mg/dl or 25(OH) D level > 100 ng /ml (toxic level) during study. Serum calcium (albumin-adjusted), phosphorus, 25(OH) D by ELISA, Alkaline phosphatase (ALP) and intact parathyroid hormone (iPTH) were monitored at baseline, 6 and 12 weeks of intervention. Both groups were maintained on their regular medications used to control mineral bone disorder as: alfacalcidol, sevelamer or a calcium-based chelator. Results Significant increase in serum 25(OH) D level in group II patients who received single dose IM Cholecalciferol after 12 w. Means of 25 (OH)D levels basal and 12 w of study were (10.54±5.14 and 13.45 ±5.72) ng/ml respectively. There was a significant increase in the mean of serum calcium basal and at 12 w (8.19±0.69 and 8.42 ±0.54) mg/dl respectively. No significant reduction in the iPTH level or any significant change in the serum phosphorus level was noticed. compared to group I with oral vitamin D, there was an insignificant change in the mean of serum 25(OH) D basal and at 12 w were (11.91±6.13 and 9.30±5.29) ng/ml respectively, associated with insignificant increase in serum calcium and an insignificant change in either the level of phosphorus or iPTH level. Conclusion Cholecalciferol 300,000 IU IM single dose showed better response on serum 25 (OH) D and calcium levels as a treatment of hemodialysis patients with Vitamin D deficiency compared to weekly oral dose for 3 months.