Monthly cholecalciferol administration in haemodialysis patients: a simple and efficient strategy for vitamin D supplementation

Nephrol. Dial. Transplant., December 2009; 24: 3799 - 3805

Study Hypothesis:

To assess the long-term efficiency and safety of monthly oral dose of cholecalciferol (100,000 iu) in a vitamin D-deficient HD population.

Study Design and Study Population

This was a prospective, observational, single center study in patients on hemodialysis.

Intervention or observation

Hemodialysis patients with a serum 25-hydroxyvitamin D (25(OH)D) level < 75nmol/l were enrolled in a 15 month prospective study.  Exclusion criteria included: use of any vitamin D derivatives, cinacalcet and bisphosphonates; uncontrolled hypercalcemia (>2.55mmol/L), hyperphosphatemia (>2mmol/L) and severe secondary hyperparathyroidism (>66 pmol/L).

Primary End Point: 25(OH)D levels

Secondary Endpoints: not clearly stated but other data was collected: PTH, 1,25(OH₂)D levels, Bone ALP, Beta cross laps, calcium, phosphate were recorded at baseline (M0), and 3 months before baseline (M-3) and then after 1 month (M1), 3 months (M3), 9 months (M9) and 15 months (M15).   Other patient data was also collected such as use of phosphate binders, dialysate calcium, and erythropoietin-stimulating agents.

Results- data from 107 patients was analyzed

Measurement	M-3	M0	M1	M3	M9	M15
25(OH)D (nmol/L) (mean + SE, range)	31 +11 (3-55)	32 +13 (7-56)	68.3 +19 (30-130)*	97.7 +28 (45-198)*	105.7 +28 (49-190)*	105.8+27 (52-192)*
% 25(OH)D >75nmol/L	0	0	46%*	82%*	88%*	91%*
1,25 (OH2)D (pmol/L, range)	14+14 (4-56)	13.7+14 (4-55)	23.8+14 (4-70)*	30.7+14 (4-82)*	49.2+17 (13-88)*	45+13 (21-86)*
PTH (pmol/L) (median, inter-quartile range)	31 (19-46)	31 (20-48)	26 (17-40)*	23 (12-32)*	21 (15-30)*	20 (12-29)*

*p< 0.05 with the baseline value

Calcium and Phosphorous levels did not change in the 15 month period.

Methodological Assessment

This study was a prospective observational study which had no control group. They also excluded patients receiving active vitamin D derivatives and/or cinacalcet and patients with PTH levels greater than 66pmol/L, P> 2 mmol/L and Ca> 2.55mmol/L. These extensive exclusion criteria would thus decrease the generalizability of the study.

Impact on Practice

This study demonstrated that monthly supplementation with 100,000 iu of cholecalciferol increased 25(OH)D levels with a slight decrease in serum PTH levels (but not clinically significant) and no effects on calcium and phosphate levels.  Further prospective randomized clinical studies are required to determine if an increase in 25(OH)D levels have any therapeutic advantages and disadvantages on clinical outcomes such as effects on bone disease and mortality.

 

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