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2014 ; 190
(5
): 533-41
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Randomized controlled trial of calcitriol in severe sepsis
#MMPMID25029202
Leaf DE
; Raed A
; Donnino MW
; Ginde AA
; Waikar SS
Am J Respir Crit Care Med
2014[Sep]; 190
(5
): 533-41
PMID25029202
show ga
RATIONALE: Vitamin D and its metabolites have potent immunomodulatory effects in
vitro, including up-regulation of cathelicidin, a critical antimicrobial protein.
OBJECTIVES: We investigated whether administration of 1,25-dihydroxyvitamin D
(calcitriol) to critically ill patients with sepsis would have beneficial effects
on markers of innate immunity, inflammation, and kidney injury. METHODS: We
performed a double-blind, randomized, placebo-controlled, physiologic study among
67 critically ill patients with severe sepsis or septic shock. Patients were
randomized to receive a single dose of calcitriol (2 ?g intravenously) versus
placebo. The primary outcome was plasma cathelicidin protein levels assessed 24
hours after study drug administration. Secondary outcomes included leukocyte
cathelicidin mRNA expression, plasma cytokine levels (IL-10, IL-6, tumor necrosis
factor-?, IL-1?, and IL-2), and urinary kidney injury markers. MEASUREMENTS AND
MAIN RESULTS: Patients randomized to calcitriol (n = 36) versus placebo (n = 31)
had similar plasma cathelicidin protein levels at 24 hours (P = 0.16).
Calcitriol-treated patients had higher cathelicidin (P = 0.04) and IL-10 (P =
0.03) mRNA expression than placebo-treated patients 24 hours after study drug
administration. Plasma cytokine levels (IL-10, IL-6, tumor necrosis factor-?,
IL-1?, and IL-2) and urinary kidney injury markers were similar in calcitriol-
versus placebo-treated patients (P > 0.05 for all comparisons). Calcitriol had no
effect on clinical outcomes nor were any adverse effects observed. CONCLUSIONS:
Calcitriol administration did not increase plasma cathelicidin protein levels in
critically ill patients with sepsis and had mixed effects on other
immunomodulatory markers. Additional phase II trials investigating the dose and
timing of calcitriol as a therapeutic agent in specific sepsis phenotypes may be
warranted. Clinical trial registered with www.clinicaltrials.gov (NCT 01689441).
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