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Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial.
JAMA. 2014 Oct 15; 312(15):1520-30.JAMA

Abstract

IMPORTANCE

Low vitamin D status is linked to increased mortality and morbidity in patients who are critically ill. It is unknown if this association is causal.

OBJECTIVE

To investigate whether a vitamin D3 treatment regimen intended to restore and maintain normal vitamin D status over 6 months is of health benefit for patients in ICUs.

DESIGN, SETTING, AND PARTICIPANTS

A randomized double-blind, placebo-controlled, single-center trial, conducted from May 2010 through September 2012 at 5 ICUs that included a medical and surgical population of 492 critically ill adult white patients with vitamin D deficiency (≤20 ng/mL) assigned to receive either vitamin D3 (n = 249) or a placebo (n = 243).

INTERVENTIONS

Vitamin D3 or placebo was given orally or via nasogastric tube once at a dose of 540,000 IU followed by monthly maintenance doses of 90,000 IU for 5 months.

MAIN OUTCOMES AND MEASURES

The primary outcome was hospital length of stay. Secondary outcomes included, among others, length of ICU stay, the percentage of patients with 25-hydroxyvitamin D levels higher than 30 ng/mL at day 7, hospital mortality, and 6-month mortality. A predefined severe vitamin D deficiency (≤12 ng/mL) subgroup analysis was specified before data unblinding and analysis.

RESULTS

A total of 475 patients were included in the final analysis (237 in the vitamin D3 group and 238 in the placebo group). The median (IQR) length of hospital stay was not significantly different between groups (20.1 days [IQR, 11.1-33.3] for vitamin D3 vs 19.3 days [IQR, 11.1-34.9] for placebo; P = .98). Hospital mortality and 6-month mortality were also not significantly different (hospital mortality: 28.3% [95% CI, 22.6%-34.5%] for vitamin D3 vs 35.3% [95% CI, 29.2%-41.7%] for placebo; hazard ratio [HR], 0.81 [95% CI, 0.58-1.11]; P = .18; 6-month mortality: 35.0% [95% CI, 29.0%-41.5%] for vitamin D3 vs 42.9% [95% CI, 36.5%-49.4%] for placebo; HR, 0.78 [95% CI, 0.58-1.04]; P = .09). For the severe vitamin D deficiency subgroup analysis (n = 200), length of hospital stay was not significantly different between the 2 study groups: 20.1 days (IQR, 12.9-39.1) for vitamin D3 vs 19.0 days (IQR, 11.6-33.8) for placebo. Hospital mortality was significantly lower with 28 deaths among 98 patients (28.6% [95% CI, 19.9%-38.6%]) for vitamin D3 compared with 47 deaths among 102 patients (46.1% [95% CI, 36.2%-56.2%]) for placebo (HR, 0.56 [95% CI, 0.35-0.90], P for interaction = .04), but not 6-month mortality (34.7% [95% CI, 25.4%-45.0%] for vitamin D3 vs 50.0% [95% CI, 39.9%-60.1%] for placebo; HR, 0.60 [95% CI, 0.39-0.93], P for interaction = .12).

CONCLUSIONS AND RELEVANCE

Among critically ill patients with vitamin D deficiency, administration of high-dose vitamin D3 compared with placebo did not reduce hospital length of stay, hospital mortality, or 6-month mortality. Lower hospital mortality was observed in the severe vitamin D deficiency subgroup, but this finding should be considered hypothesis generating and requires further study.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01130181.

Authors+Show Affiliations

Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Austria.Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Austria.Division of Neurogeriatrics, Department of Neurology, Medical University of Graz, Austria.Institute for Medical Informatics, Statistics, and Documentation, Medical University of Graz, Austria.Renal Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Austria.Division of General Neurology, Department of Neurology, Medical University of Graz, Austria.Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Austria.Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Austria.Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Austria.Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria.Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria.Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Austria.Medical Intensive Care Unit, Department of Internal Medicine, Medical University of Graz, Austria.Institute for Medical Informatics, Statistics, and Documentation, Medical University of Graz, Austria.Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Austria.Division of Endocrinology and Metabolism, Department of Internal Medicine, Medical University of Graz, Austria10Schilddrüsen-Endokrinologie-Osteoporose Institut Dobnig GmbH, Graz, Austria.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25268295

Citation

Amrein, Karin, et al. "Effect of High-dose Vitamin D3 On Hospital Length of Stay in Critically Ill Patients With Vitamin D Deficiency: the VITdAL-ICU Randomized Clinical Trial." JAMA, vol. 312, no. 15, 2014, pp. 1520-30.
Amrein K, Schnedl C, Holl A, et al. Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA. 2014;312(15):1520-30.
Amrein, K., Schnedl, C., Holl, A., Riedl, R., Christopher, K. B., Pachler, C., Urbanic Purkart, T., Waltensdorfer, A., Münch, A., Warnkross, H., Stojakovic, T., Bisping, E., Toller, W., Smolle, K. H., Berghold, A., Pieber, T. R., & Dobnig, H. (2014). Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. JAMA, 312(15), 1520-30. https://doi.org/10.1001/jama.2014.13204
Amrein K, et al. Effect of High-dose Vitamin D3 On Hospital Length of Stay in Critically Ill Patients With Vitamin D Deficiency: the VITdAL-ICU Randomized Clinical Trial. JAMA. 2014 Oct 15;312(15):1520-30. PubMed PMID: 25268295.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of high-dose vitamin D3 on hospital length of stay in critically ill patients with vitamin D deficiency: the VITdAL-ICU randomized clinical trial. AU - Amrein,Karin, AU - Schnedl,Christian, AU - Holl,Alexander, AU - Riedl,Regina, AU - Christopher,Kenneth B, AU - Pachler,Christoph, AU - Urbanic Purkart,Tadeja, AU - Waltensdorfer,Andreas, AU - Münch,Andreas, AU - Warnkross,Helga, AU - Stojakovic,Tatjana, AU - Bisping,Egbert, AU - Toller,Wolfgang, AU - Smolle,Karl-Heinz, AU - Berghold,Andrea, AU - Pieber,Thomas R, AU - Dobnig,Harald, PY - 2014/10/1/entrez PY - 2014/10/1/pubmed PY - 2014/11/2/medline SP - 1520 EP - 30 JF - JAMA JO - JAMA VL - 312 IS - 15 N2 - IMPORTANCE: Low vitamin D status is linked to increased mortality and morbidity in patients who are critically ill. It is unknown if this association is causal. OBJECTIVE: To investigate whether a vitamin D3 treatment regimen intended to restore and maintain normal vitamin D status over 6 months is of health benefit for patients in ICUs. DESIGN, SETTING, AND PARTICIPANTS: A randomized double-blind, placebo-controlled, single-center trial, conducted from May 2010 through September 2012 at 5 ICUs that included a medical and surgical population of 492 critically ill adult white patients with vitamin D deficiency (≤20 ng/mL) assigned to receive either vitamin D3 (n = 249) or a placebo (n = 243). INTERVENTIONS: Vitamin D3 or placebo was given orally or via nasogastric tube once at a dose of 540,000 IU followed by monthly maintenance doses of 90,000 IU for 5 months. MAIN OUTCOMES AND MEASURES: The primary outcome was hospital length of stay. Secondary outcomes included, among others, length of ICU stay, the percentage of patients with 25-hydroxyvitamin D levels higher than 30 ng/mL at day 7, hospital mortality, and 6-month mortality. A predefined severe vitamin D deficiency (≤12 ng/mL) subgroup analysis was specified before data unblinding and analysis. RESULTS: A total of 475 patients were included in the final analysis (237 in the vitamin D3 group and 238 in the placebo group). The median (IQR) length of hospital stay was not significantly different between groups (20.1 days [IQR, 11.1-33.3] for vitamin D3 vs 19.3 days [IQR, 11.1-34.9] for placebo; P = .98). Hospital mortality and 6-month mortality were also not significantly different (hospital mortality: 28.3% [95% CI, 22.6%-34.5%] for vitamin D3 vs 35.3% [95% CI, 29.2%-41.7%] for placebo; hazard ratio [HR], 0.81 [95% CI, 0.58-1.11]; P = .18; 6-month mortality: 35.0% [95% CI, 29.0%-41.5%] for vitamin D3 vs 42.9% [95% CI, 36.5%-49.4%] for placebo; HR, 0.78 [95% CI, 0.58-1.04]; P = .09). For the severe vitamin D deficiency subgroup analysis (n = 200), length of hospital stay was not significantly different between the 2 study groups: 20.1 days (IQR, 12.9-39.1) for vitamin D3 vs 19.0 days (IQR, 11.6-33.8) for placebo. Hospital mortality was significantly lower with 28 deaths among 98 patients (28.6% [95% CI, 19.9%-38.6%]) for vitamin D3 compared with 47 deaths among 102 patients (46.1% [95% CI, 36.2%-56.2%]) for placebo (HR, 0.56 [95% CI, 0.35-0.90], P for interaction = .04), but not 6-month mortality (34.7% [95% CI, 25.4%-45.0%] for vitamin D3 vs 50.0% [95% CI, 39.9%-60.1%] for placebo; HR, 0.60 [95% CI, 0.39-0.93], P for interaction = .12). CONCLUSIONS AND RELEVANCE: Among critically ill patients with vitamin D deficiency, administration of high-dose vitamin D3 compared with placebo did not reduce hospital length of stay, hospital mortality, or 6-month mortality. Lower hospital mortality was observed in the severe vitamin D deficiency subgroup, but this finding should be considered hypothesis generating and requires further study. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01130181. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/25268295/Effect_of_high_dose_vitamin_D3_on_hospital_length_of_stay_in_critically_ill_patients_with_vitamin_D_deficiency:_the_VITdAL_ICU_randomized_clinical_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2014.13204 DB - PRIME DP - Unbound Medicine ER -