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Clin J Am Soc Nephrol. 2015 Apr 7;10(4):611-9. doi: 10.2215/CJN.06910714. Epub 2015 Mar 13.

Nutritional vitamin D supplementation in dialysis: a randomized trial.

Author information

1
Division of Nephrology, Department of Medicine, ibhan@mgh.harvard.edu.
2
Division of Nephrology, Department of Medicine.
3
Department of Medicine, Division of Biological Sciences, The University of Chicago, Chicago, Illinois.
4
Infectious Disease Unit, Departments of Pediatrics and Medicine, and.
5
Pharmacy Department, Massachusetts General Hospital, Boston, Massachusetts; and.

Abstract

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.

KEYWORDS:

ESRD; clinical trial; dialysis; vitamin D

PMID:
25770176
PMCID:
PMC4386253
DOI:
10.2215/CJN.06910714
[Indexed for MEDLINE]
Free PMC Article

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