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
Amrein K, Schnedl C, Holl A, Riedl R, Christopher KB, Pachler C, Urbanic Purkart T, Waltensdorfer A, Münch A, Warnkross H, Stojakovic T, Bisping E, Toller W, Smolle KH, Berghold A, Pieber TR, Dobnig H
JAMA · 340 citas
Etiquetas de revisión
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2014-09-30 · JAMA · vol. 312 · número 15 · pág. 1520
- Editorial
- American Medical Association
- Citado
- 493 citas · más que el 100% de estudios similares · 29.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 29 trabajos
- Acceso
- De pago
- Áreas de investigación
- Vitamin D Research Studies · Intensive Care Unit Cognitive Disorders · Burn Injury Management and Outcomes
- Palabras clave
- vitamin D3 supplementation, vitamin D deficiency, critically ill patients, length of hospital stay, ICU length of stay, 25-hydroxyvitamin D, in-hospital mortality, 6-month mortality, high-dose vitamin D, maintenance dosing, critically ill adults, nasogastric tube administration
- MeSH
- humans, vitamin d deficiency, critical illness, cholecalciferol, vitamins, length of stay, hospital mortality, double-blind method, aged, middle aged, intensive care units, female, male
17 autores
- Karin Amrein🇦🇹 · autor de correspondenciaMedical University of Graz
- Christian Schnedl🇦🇹Medical University of Graz
- Alexander Höll🇦🇹Medical University of Graz
- Regina Riedl🇦🇹Medical University of Graz
- Kenneth B. Christopher🇺🇸Brigham and Women's Hospital; Harvard University
- Christoph Pachler🇦🇹Medical University of Graz
- Tadeja Urbanic Purkart🇦🇹Medical University of Graz
- Andreas Waltensdorfer🇦🇹Medical University of Graz
- Andreas Münch🇦🇹Medical University of Graz
- Helga Warnkross🇦🇹Medical University of Graz
- Tatjana Stojaković🇦🇹Medical University of Graz
- Egbert Hubertus Bisping🇦🇹Medical University of Graz
- Wolfgang G Toller🇦🇹Medical University of Graz
- Karl‐Heinz Smolle🇦🇹Medical University of Graz
- Andrea Berghold🇦🇹Medical University of Graz
- Thomas Rudolf Pieber🇦🇹Medical University of Graz
- Harald Dobnig🇦🇹Medical University of Graz
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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