Biochemical Parameters After Cholecalciferol Repletion in Hemodialysis: Results From the VitaDial Randomized Trial

• Published in: American journal of kidney diseases Vol. 64; no. 5; pp. 696 - 705
• Main Authors: Massart, Annick, MD, Debelle, Frédéric Daniel, MD, PhD, Racapé, Judith, PhD, Gervy, Christine, PhD, Husson, Cécile, BsT, Dhaene, Michel, MD, Wissing, Karl Martin, MD, PhD, Nortier, Joëlle Louise, MD, PhD
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.11.2014; Elsevier
• Subjects: 1,25-dihydroxyvitamin D; 25-hydroxyvitamin D; Aged; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; aortic calcification score; Biological and medical sciences; bone fracture; calcitriol; calcium; Cholecalciferol; Cholecalciferol - administration & dosage; Cholecalciferol - blood; clinical practice guidelines; Double-Blind Method; Emergency and intensive care: renal failure. Dialysis management; falls; Female; fetuin A; fibroblast growth factor 23 (FGF-23); Follow-Up Studies; hemodialysis; Humans; Intensive care medicine; Longitudinal Studies; Male; Medical sciences; Middle Aged; Nephrology; Nephrology. Urinary tract diseases; nutritional vitamin D; parathyroid hormone (PTH); Prospective Studies; Renal Dialysis - methods; Renal Insufficiency, Chronic - blood; Renal Insufficiency, Chronic - therapy; vascular calcification; vitamin D; Vitamin D - blood; vitamin D deficiency; vitamin D repletion; calcium; 25-hydroxyvitamin D; Cholecalciferol; vitamin D; nutritional vitamin D; vascular calcification; fetuin A; parathyroid hormone (PTH); vitamin D repletion; aortic calcification score; vitamin D deficiency; clinical practice guidelines; fibroblast growth factor 23 (FGF-23); falls; calcitriol; 1,25-dihydroxyvitamin D; bone fracture; hemodialysis; Nephrology; Hemodialysis; Diseases of the osteoarticular system; Biochemistry; Inorganic element; Extrarenal dialysis; Vitamin D; Blood vessel; Aorta; Colecalciferol; Steroid hormone; Cholecalciferol(1,25-dihydroxy); Trauma; Artery; Recommendation; Score; Parathyroid hormone; Calcification; Fall; Calcium; Fibroblast growth factor 23; Peptide hormone; Calcitriol; Fracture; Urology; Osteoarticular system; Randomization; Clinical trial; Nutritional status; Nutrition disorder; Serum protein; Cholecalciferol(25-hydroxy); Parameter; Circulatory system; Bone
• ISSN: 0272-6386; 1523-6838
• DOI: 10.1053/j.ajkd.2014.04.020

Background The 2009 KDIGO (Kidney Disease: Improving Global Outcomes) chronic kidney disease–mineral and bone disorder clinical practice guideline suggests correcting 25-hydroxyvitamin D3 (25[OH]D) levels < 30 ng/mL in patients treated with maintenance hemodialysis, but does not provide a specific treatment protocol. Study Design 2-center, double-blind, randomized, 13-week, controlled trial followed by a 26-week open-label study. Setting & Participants 55 adult maintenance hemodialysis patients with 25(OH)D levels < 30 ng/mL were recruited from June 2008 through October 2009. Intervention Cholecalciferol, 25,000 IU, per week orally versus placebo for 13 weeks, then 26 weeks of individualized cholecalciferol prescription based on NKF-KDOQI (National Kidney Foundation–Kidney Disease Outcomes Quality Initiative) guidelines. Outcomes Primary end point was the percentage of patients with 25(OH)D levels ≥ 30 ng/mL at 13 weeks. Secondary outcomes included the percentage of patients with normal calcium, phosphorus, and intact parathyroid hormone (iPTH) blood levels. Safety measures included incidence of hypercalcemia and hypervitaminosis D. Measurements Blood calcium and phosphate were measured weekly; iPTH, 25(OH)D, 1,25-dihydroxyvitamin D3 (1,25[OH]2 D), and bone turnover markers, trimonthly; fetuin A and fibroblast growth factor 23 (FGF-23) serum levels and aortic calcification scores were determined at weeks 0 and 39. Results The primary end point significantly increased in the treatment group compared with the placebo group (61.5% vs 7.4%; P < 0.001), as well as 1,25(OH)2 D levels (22.5 [IQR, 15-26] vs 11 [IQR, 10-15] pg/mL; P < 0.001) and the proportion of patients achieving the target calcium level (76.9% vs 48.2%; P = 0.03). Incidence of hypercalcemia and phosphate and iPTH levels were similar between groups. The second 26-week study phase did not significantly modify the prevalence of 25(OH)D level ≥ 30 ng/mL in patients issued from the placebo group. Limitations Small size of the study population. Conclusions Oral weekly administration of 25,000 IU of cholecalciferol for 13 weeks is an effective, safe, inexpensive, and manageable way to increase 25(OH)D and 1,25(OH)2 D levels in hemodialysis patients. Further evaluation of clinical end points is suggested.