Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Schnedl, C.
VITdAL@ICU - Correction of Vitamin D deficiency in critically ill patients: a randomized, double-blind, placebo-controlled trial
[ Dissertation ] Medical University of Graz; 2013. pp. 121
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- Autor*innen der Med Uni Graz:
- Schnedl Christian
- Betreuer*innen:
- Amrein Karin
- Dobnig Harald
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- Abstract:
- Background: A low vitamin D status is associated with increased morbidity and mortality in the general population and in critically ill patients. However, no randomized controlled trial has yet evaluated whether treatment with a sufficiently large dose of vitamin D can improve the clinical outcome of patients in an intensive care setting. Methods: In this randomized, double-blind, placebo-controlled, single-center trial in five intensive care units of a large academic center, we assigned a mixed population of 480 critically ill adults with vitamin D deficiency (¿20ng/ml) to receive either placebo or high-dose vitamin D3. An initial loading dose of 540,000IU cholecalciferol applied orally or via feeding tube was followed by five monthly maintenance doses of 90,000IU for a total follow-up period of 6 months. The primary endpoint was length of hospital stay. Results: In the intervention group, mean 25(OH)D increased from a baseline level of 13.0 ± 4.8 to 35.5 ± 20.6ng/ml after 7 days and the percentage of patients who achieved vitamin D sufficiency (>30ng/ml) was 52.5% within this period. Hospital length of stay was similar in the placebo group compared with the vitamin D group (median 19.3 vs 20.1 days, p=0.981), as was length of ICU stay (median 10.7 vs. 9.6 days, p=0.384). Overall, there was a trend towards a lower hospital- and 6-month mortality in the vitamin D group compared to the placebo group (28.3% vs. 35.3%, p=0.121 and 35.0% vs. 42.9%, p=0.087). This was statistically significant in the predefined subgroup with severe vitamin D deficiency at baseline (¿12ng/ml, n=200), as both hospital- and 6-month mortality were significantly reduced by high-dose vitamin D supplementation (28.6% vs. 46.1%, p=0.010 and 34.7% vs. 50.0%, p=0.021). Adverse events including hypercalcemia, hypercalciuria, falls and fractures were not different between the treatment groups during the 6-month follow-up period. Conclusions: High-dose oral vitamin D3 did not significantly reduce hospital length of stay as compared with placebo in mixed critically ill patients. However, hospital- and 6-month mortality tended to be lower in the entire group and was significantly lower in patients with severe vitamin D deficiency. Larger intervention trials are necessary to confirm our findings and evaluate a possible weaker effect in patients with moderate vitamin D deficiency. ClinicalTrials.gov number: NCT01130181