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Critical Care
Published in: Critical Care 2/2011

Open Access 01-04-2011 | Research

Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study

Authors: Karin Amrein, Harald Sourij, Gerit Wagner, Alexander Holl, Thomas R Pieber, Karl Heinz Smolle, Tatjana Stojakovic, Christian Schnedl, Harald Dobnig

Published in: Critical Care | Issue 2/2011

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Abstract

Introduction

Vitamin D deficiency is encountered frequently in critically ill patients and might be harmful. Current nutrition guidelines recommend very low vitamin D doses. The objective of this trial was to evaluate the safety and efficacy of a single oral high-dose vitamin D3 supplementation in an intensive care setting over a one-week observation period.

Methods

This was a randomized, double-blind, placebo-controlled pilot study in a medical ICU at a tertiary care university center in Graz, Austria. Twenty-five patients (mean age 62 ± 16yrs) with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤20 ng/ml] and an expected stay in the ICU >48 hours were included and randomly received either 540,000 IU (corresponding to 13.5 mg) of cholecalciferol (VITD) dissolved in 45 ml herbal oil or matched placebo (PBO) orally or via feeding tube.

Results

The mean serum 25(OH)D increase in the intervention group was 25 ng/ml (range 1-47 ng/ml). The highest 25(OH)D level reached was 64 ng/ml, while two patients showed a small (7 ng/ml) or no response (1 ng/ml). Hypercalcemia or hypercalciuria did not occur in any patient. From day 0 to day 7, total serum calcium levels increased by 0.10 (PBO) and 0.15 mmol/L (VITD; P < 0.05 for both), while ionized calcium levels increased by 0.11 (PBO) and 0.05 mmol/L (VITD; P < 0.05 for both). Parathyroid hormone levels decreased by 19 and 28 pg/ml (PBO and VITD, ns) over the seven days, while 1,25(OH)D showed a transient significant increase in the VITD group only.

Conclusions

This pilot study shows that a single oral ultra-high dose of cholecalciferol corrects vitamin D deficiency within 2 days in most patients without causing adverse effects like hypercalcemia or hypercalciuria. Further research is needed to confirm our results and establish whether vitamin D supplementation can affect the clinical outcome of vitamin D deficient critically ill patients.

EudraCT Number

2009-012080-34

German Clinical Trials Register (DRKS)

DRKS00000750
Appendix
Available only for authorised users
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Metadata
Title
Short-term effects of high-dose oral vitamin D3 in critically ill vitamin D deficient patients: a randomized, double-blind, placebo-controlled pilot study
Authors
Karin Amrein
Harald Sourij
Gerit Wagner
Alexander Holl
Thomas R Pieber
Karl Heinz Smolle
Tatjana Stojakovic
Christian Schnedl
Harald Dobnig
Publication date
01-04-2011
Publisher
BioMed Central
Published in
Critical Care / Issue 2/2011
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/cc10120

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