Tunon, JoseGonzalez-Hernandez, IgnacioLlanos-Jimenez, LuciaAlonso-Martin, JoaquinEscudier-Villa, Juan M.Tarin, NievesCristobal, CarmenSanz, PetraPello, Ana M.Acena, AlvaroCarda, RocioOrejas, MiguelTomas, MartaBeltran, PaulaCalero Rueda, MartaMarcos, EstherMaria Serrano-Antolin, JoseGutierrez-Landaluce, CarlosJimenez, RosaCabezudo, JorgeCurcio, AlejandroPeces-Barba, GermanGonzalez-Parra, EmilioMunoz-Siscart, RaquelLuisa Gonzalez-Casaus, MariaLorenzo, AntonioHuelmos, AnaGoicolea, JavierIbáñez, BorjaHernandez, GonzaloAlonso-Pulpon, LuisFarre, JeronimoLorenzo, OscarMahillo-Fernandez, IgnacioEgido, Jesus2017-10-302017-10-302016BMJ Open. 2016; 6(8):e0112872044-6055http://hdl.handle.net/20.500.12105/5247Introduction:Decreased plasma vitamin D (VD) levels are linked to cardiovascular damage. However, clinical trials have not demonstrated a benefit of VD supplements on left ventricular (LV) remodelling. Anterior ST-elevation acute myocardial infarction (STEMI) is the best human model to study the effect of treatments on LV remodelling. We present a proof-of-concept study that aims to investigate whether VD improves LV remodelling in patients with anterior STEMI. Methods and analysis:The VITamin D in Acute Myocardial Infarction (VITDAMI) trial is a multicentre, randomised, double-blind, placebo-controlled trial. 144 patients with anterior STEMI will be assigned to receive calcifediol 0.266 mg capsules (Hidroferol SGC)/15 days or placebo on a 2:1 basis during 12 months. Primary objective:to evaluate the effect of calcifediol on LV remodelling defined as an increase in LV end-diastolic volume >= 10\% (MRI). Secondary objectives:change in LV end-diastolic and end-systolic volumes, ejection fraction, LV mass, diastolic function, sphericity index and size of fibrotic area; endothelial function; plasma levels of aminoterminal fragment of B-type natriuretic peptide, galectin-3 and monocyte chemoattractant protein-1; levels of calcidiol (VD metabolite) and other components of mineral metabolism (fibroblast growth factor-23 (FGF-23), the soluble form of its receptor klotho, parathormone and phosphate). Differences in the effect of VD will be investigated according to the plasma levels of FGF-23 and klotho. Treatment safety and tolerability will be assessed. This is the first study to evaluate the effect of VD on cardiac remodelling in patients with STEMI. Ethics and dissemination: This trial has been approved by the corresponding Institutional Review Board (IRB) and National Competent Authority (Agencia Espanola de Medicamentos y Productos Sanitarios (AEMPS)). It will be conducted in accordance with good clinical practice (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Practice (ICH-GCP)) requirements, ethical principles of the Declaration of Helsinki and national laws. The results will be submitted to indexed medical journals and national and international meetings.engVoRhttp://creativecommons.org/licenses/by-nc/4.0/CORONARY-ARTERY-DISEASECHRONIC KIDNEY-DISEASEFIBROBLAST GROWTH FACTOR-23CARDIOVASCULAR-DISEASEPARATHYROID-HORMONED DEFICIENCYSERUM 25-HYDROXYVITAMIN-DALL-CAUSERISKMORTALITYAtribución-NoComercial 4.0 Internacional27496232610.1136/bmjopen-2016-011287BMJ Openopen access