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Vitamin D intervention increased by 20 percent the survival of critically ill patients- RCT June 2014

Correction of Vitamin D Deficiency in Critically Ill Patients: A Randomized Placebo-Controlled Trial

ENDO 2014 Conference in Chicaro: Posters
Session: SAT 0229-0266-Vitamin D Metabolism & Action
Saturday, June 21, 2014: 1:00 PM-3:00 PM; Hall F (McCormick Place West Building)

Karin Amrein, MD, MSc1, Christian Schnedl, MD2, Alexander Holl3, Regina Riedl4, Kenneth B. Christopher5, Tadeja Urbanic-Purkart4, Andrea Berghold4, Thomas R Pieber4, Christoph Pachler4, Andreas Waltensdorfer4, Andreas Münch4, Tatjana Stojakovic4, Egbert Bisping4, Wolfgang Toller4 and Harald Dobnig, MD6
1Medical Univ of Graz, Graz, Austria, 2Medical University Graz, Graz, Austria, 3Department of Neurology, 4Medical University of Graz, 5Renal Division, Brigham and Women's Hospital, 6Schilddruesen|Endokrinologie|Institut, Graz, Austria

Introduction: Observational studies have shown an association between low vitamin D status and poor outcomes including increased mortality in critically ill patients. Whether this relationship is causal remains unclear to date.

Methods: In this randomized, double-blind, placebo-controlled single-center trial, five intensive care units assigned a mixed medical and surgical population of 480 adult patients with vitamin D deficiency (≤20 ng/ml) to either vitamin D or placebo. Vitamin D3 was given orally or via nasogastric tube once at a dose of 540,000 IU followed by 5 monthly maintenance doses of 90,000 IU.

Results: Vitamin D3 administration led to an immediate and sustained rise of mean 25-hydroxyvitamin D levels in the interventional vs. the placebo group: 13.0±4.0 vs.13.1±4.3 (baseline); 35.5±20.6 vs. 14.5±5.1 ng/ml (day 7; P<0.001). The primary endpoint, length of hospital stay, was comparable between groups (median 20.1 vs. 19.3 days, P=0.98).
Hospital- and 6-month mortality rates in contrast, tended to be lower in the vitamin D group [HR 0.81 (95%CI 0.58-1.11), P=0.18 and HR 0.78 (0.58-1.04), P=0.09, respectively].

In the predefined subgroup analysis of patients with severe vitamin D deficiency (≤12 ng/ml, n=200), hospital- and 6-month mortality rates were significantly reduced [HR 0.56 (95%CI 0.35-0.90), P=0.01 and HR 0.60 (0.39-0.93), P=0.02, respectively]. At the 6-month follow up, patients with severe vitamin D deficiency at baseline did not show any significant changes in investigated parameters compared to the placebo group whereas patients with less severe vitamin D deficiency (baseline 25(OH)D level >12 and ≤20 ng/ml) showed significantly improved grip strength of the right hand as well as a higher physical component summary score of the SF-12 questionnaire. Adverse event rates including hypercalcemia, falls and fractures were similar in both groups.

Conclusions: High-dose vitamin D3 in critically ill patients did not change the length of hospital stay but tended to decrease hospital- and 6-month mortality. In patients with severe vitamin D deficiency, vitamin D3 reduced all cause mortality, as compared with placebo. (ClinicalTrials.gov number: NCT01130181)

Nothing to Disclose: KA, CS, AH, RR, KBC, TU, AB, TRP, CP, AW, AM, TS, EB, WT, HD

See also VitaminDWiki


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