Financiado en parte por Merck KGaA
Effect of vitamin D on all-cause mortality in heart failure (EVITA): a 3-year randomized clinical trial with 4000 IU vitamin D daily
Zittermann A, Ernst JB, Prokop S, Fuchs U, Dreier J, Kuhn J, Knabbe C, Birschmann I, Schulz U, Berthold HK, Pilz S, Gouni-Berthold I, Gummert JF, Dittrich M, Börgermann J
European heart journal · 142 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
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
- Financiado por la industria
- Empresa
- Merck KGaA
- Subvenciones
- Merck KGaA (EMR200109-616)
Según 1 financiador declarado.
Publicación
- Publicado
- 2017-04-24 · Eur Heart J · vol. 38 · número 29 · págs. 2279–2286
- Editorial
- Oxford University Press
- Citado
- 180 citas · más que el 100% de estudios similares · 14.9× 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 · Heart Failure Treatment and Management · Parathyroid Disorders and Treatments
- Palabras clave
- vitamin D supplementation, heart failure, all-cause mortality, 25-hydroxyvitamin D, mechanical circulatory support, hypercalcemia, heart transplantation, hospitalization, resuscitation
- MeSH
- humans, cardiomyopathy, dilated, myocardial ischemia, vitamin d deficiency, vitamins, vitamin d, treatment outcome, hospitalization, heart-assist devices, heart transplantation, cause of death, risk factors, prospective studies, dietary supplements, middle aged, female, male, heart failure, kaplan-meier estimate
15 autores
- Armin Zittermann🇩🇪 · autor de correspondenciaHeart and Diabetes Center North Rhine-Westphalia; Ruhr University Bochum
- Jana Barbara Ernst🇩🇪Heart and Diabetes Center North Rhine-Westphalia; Ruhr University Bochum
- Sylvana Prokop🇩🇪Heart and Diabetes Center North Rhine-Westphalia; Ruhr University Bochum
- Uwe Fuchs🇩🇪Heart and Diabetes Center North Rhine-Westphalia; Ruhr University Bochum
- Jens Dreier🇩🇪Heart and Diabetes Center North Rhine-Westphalia; Ruhr University Bochum
- Joachim Kühn🇩🇪Heart and Diabetes Center North Rhine-Westphalia; Ruhr University Bochum
- Cornelius Knabbe🇩🇪Heart and Diabetes Center North Rhine-Westphalia; Ruhr University Bochum
- Ingvild Birschmann🇩🇪Heart and Diabetes Center North Rhine-Westphalia; Ruhr University Bochum
- Uwe Schulz🇩🇪Heart and Diabetes Center North Rhine-Westphalia; Ruhr University Bochum
- Heiner K. Berthold🇩🇪Evangelisches Krankenhaus Bielefeld
- Stefan Pilz🇦🇹Medical University of Graz
- Ioanna Gouni‐Berthold🇩🇪University of Cologne
- Jan Fritz Gummert🇩🇪Heart and Diabetes Center North Rhine-Westphalia; Ruhr University Bochum
- Marcus T. Dittrich🇩🇪University of Würzburg
- Jochen Börgermann🇩🇪Heart and Diabetes Center North Rhine-Westphalia; Ruhr University Bochum
Resumen
El texto original del estudio, en el idioma en que se publicó.
Aims
Circulating 25-hydroxyvitamin D (25OHD) levels <75 nmol/L are associated with a nonlinear increase in mortality risk. Such 25OHD levels are common in heart failure (HF). We therefore examined whether oral vitamin D supplementation reduces mortality in patients with advanced HF.
Methods and results
Four hundred HF patients with 25OHD levels <75 nmol/L were randomized to receive 4000 IU vitamin D daily or matching placebo for 3 years. Primary endpoint was all-cause mortality. Key secondary outcome measures included hospitalization, resuscitation, mechanical circulatory support (MCS) implant, high urgent listing for heart transplantation, heart transplantation, and hypercalcaemia. Initial 25OHD levels were on average <40 nmol/L, remained around 40 nmol/L in patients assigned to placebo and plateaued around 100 nmol/L in patients assigned to vitamin D. Mortality was not different in patients receiving vitamin D (19.6%; n = 39) or placebo (17.9%; n = 36) with a hazard ratio (HR) of 1.09 [95% confidence interval (CI): 0.69-1.71; P = 0.726]. The need for MCS implant was however greater in patients assigned to vitamin D (15.4%, n = 28) vs. placebo [9.0%, n = 15; HR: 1.96 (95% CI: 1.04-3.66); P = 0.031]. Other secondary clinical endpoints were similar between groups. The incidence of hypercalcaemia was 6.2% (n = 10) and 3.1% (n = 5) in patients receiving vitamin D or placebo (P = 0.192).
Conclusion
A daily vitamin D dose of 4000 IU did not reduce mortality in patients with advanced HF but was associated with a greater need for MCS implants. Data indicate caution regarding long-term supplementation with moderately high vitamin D doses.
Trial registration information
clinicaltrials.gov Idenitfier: NCT01326650.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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