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Hemodialysis not helped by weekly vitamin D2 – RCT April 2015

Nutritional Vitamin D Supplementation in Dialysis: A Randomized Trial

CJASN April 07, 2015 vol. 10 no. 4 611-619
Ishir Bhan*, Dorothy Dobens*, Hector Tamez*, Joseph J. Deferio*, Yan Chun Li†, H. Shaw Warren‡, Elizabeth Ankers*, Julia Wenger*, J. Kevin Tucker*, Caitlin Trottier*, Fridosh Pathan§, Sahir Kalim*, Sagar U. Nigwekar*, Ravi Thadhani*
*Division of Nephrology, Department of Medicine,
‡Infectious Disease Unit, Departments of Pediatrics and Medicine, and
§Pharmacy Department, Massachusetts General Hospital, Boston, Massachusetts; and
†Department of Medicine, Division of Biological Sciences, The University of Chicago, Chicago, Illinois
Dr. Ishir Bhan, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 750, Boston, MA 02114. Email: ibhan at mgh.harvard.edu

Background and objectives Vitamin D (25-hydroxyvitamin D; 25[OH]D) deficiency is common in patients initiating long-term hemodialysis, but the safety and efficacy of nutritional vitamin D supplementation in this population remain uncertain.

Design, setting, participants, & measurements This randomized, placebo-controlled, parallel-group multicenter trial compared two doses of ergocalciferol with placebo between October 2009 and March 2013. Hemodialysis patients (n=105) with 25(OH)D levels ≤32 ng/ml from 32 centers in the Northeast United States were randomly assigned to oral ergocalciferol, 50,000 IU weekly (n=36) or monthly (n=33), or placebo (n=36) for a 12-week treatment period. The primary endpoint was the achievement of vitamin D sufficiency (25[OH]D >32 ng/ml) at the end of the 12-week treatment period. Survival was assessed through 1 year.

Results Baseline characteristics were similar across all arms, with overall mean ±SD 25(OH)D levels of 21.9±6.9 ng/ml. At 12 weeks, vitamin D sufficiency (25[OH]D >32 ng/ml) was achieved in 91% (weekly), 66% (monthly), and 35% (placebo) (P<0.001). Mean 25(OH)D was significantly higher in both the weekly (49.8±2.3 ng/ml; P<0.001) and monthly (38.3±2.4 ng/ml; P=0.001) arms compared with placebo (27.4±2.3 ng/ml). Calcium, phosphate, parathyroid hormone levels, and active vitamin D treatment did not differ between groups. All-cause and cause-specific hospitalizations and adverse events were similar between groups during the intervention period. Lower all-cause mortality among ergocalciferol-treated participants was not statistically significant (hazard ratio, 0.28; 95% confidence interval, 0.07 to 1.19).

Conclusions Oral ergocalciferol can increase 25(OH)D levels in incident hemodialysis patients without significant alterations in blood calcium, phosphate, or parathyroid hormone during a 12-week period.