Background: There is growing evidence of the usefulness of vitamin D supplementation in dialysis patients who are most often vitamin D deficient. Due to the long half-life of vitamin D, there is much interest in administering it intermittently for long-term adherence. However, there are no data to indicate which dosage would be most efficient. Objective. The aim was to assess the long-term efficiency and safety of a monthly oral dose of cholecalciferol (100 000 IU) in vitamin D-deficient haemodialysis (HD) patients.
Methods: HD patients with a serum 25-hydroxyvitamin D (25(OH)D) level <75 nmol/L were enrolled in a 15-month prospective study. The exclusion criteria were as follows: use of any vitamin D derivatives, prescription of cinacalcet and bisphosphonates, uncontrolled hypercalcaemia (>2.55 mmol/L), hyperphosphataemia (>2 mmol/L) and severe secondary hyperparathyroidism (SHPT; serum PTH >600 pg/mL). Biological data were recorded in the following months: M-3, M0, M1, M3, M9 and M15. We aimed to maintain stable levels of the phosphate binder and oral and dialysate calcium during the course of the study.
Results: Of the 250 patients screened, 161 were enrolled, and the results from 107 were recorded at the end of the study. Of these 107 patients, 56% were males, and the average age of the patient group was 66.4 +/- 15 years. Diabetics accounted for 36% of the total patients. The dialysis schedule ranged from 3 x 5 to 3 x 8 h, with a mean dialysate calcium concentration of 1.48 +/- 0.6 mmol/L. After 15 months, the mean serum 25(OH)D level increased from 32 +/- 13 to 105.8 +/- 27 nmol/L (P < 0.001) and plateaued after M3. Of the patients, 91% had a level higher than the target level (>75 nmol/L), while none had levels >200 nmol/L. The serum calcitriol (1,25(OH)(2)D) level increased from 13.7 +/- 14 to 45 +/- 13 pmol/L (P < 0.001) and plateaued after M9. The levels of serum PTH (median 295-190 pg/mL, P < 0.001), bone alkaline phosphatase (20.5 +/- 9-17.1 +/- 7 microg/L, P < 0.05) and beta-cross-laps (2.5 +/- 1-2.07 +/- 0.8 microg/L, P < 0.05) decreased significantly. No significant changes were observed in the values of the following: calcaemia, phosphataemia, blood pressure, serum albumin, haemoglobin and C-reactive protein.
Conclusions: Long-term monthly administration of oral cholecalciferol (100 000 IU) was a safe, effective, inexpensive and simple method for correcting vitamin D deficiency in almost 90% of the HD patients in this study and led to optimal compliance. The most evident consequences were a slight decrease in the levels of PTH and bone markers and an increase in the level of serum 1,25(OH)(2)D.