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

Karin Amrein12, Harald Sourij1, Gerit Wagner3, Alexander Holl4, Thomas R Pieber1, Karl Heinz Smolle2, Tatjana Stojakovic5, Christian Schnedl1 and Harald Dobnig1*

Author Affiliations

1 Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism, Auenbruggerplatz 15, 8036 Graz, Austria

2 Medical University of Graz, Department of Internal Medicine, Medical Intensive Care Unit, Auenbruggerplatz 15, 8036 Graz, Austria

3 Medical University of Graz, Department of Medical Informatics, Statistics and Documentation, Auenbruggerplatz 2, 8036 Graz, Austria

4 Medical University of Graz, Department of Neurology, Division of Special Neurology, Auenbruggerplatz 22, 8036 Graz, Austria

5 Medical University of Graz, Clinical Institute of Medical and Chemical Laboratory Diagnostics, Auenbruggerplatz 15, 8036 Graz, Austria

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Critical Care 2011, 15:R104  doi:10.1186/cc10120


Please see related commentary by Lee, http://ccforum.com/content/15/2/154

Published: 28 March 2011

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