Hypovitaminosis D and organ damage in patients with arterial hypertension: a multicenter double blind randomised controlled trial of cholecalciferol supplementation (HYPODD) : study design, clinical procedures and treatment protocol
| Autor: | Carmelinda Ruggiero, Francesco Fallo, Gian Carlo Isaia, Pasquale Strazzullo, Gilberta Giacchetti, Elena Spertino, Cristiana Catena, Bruno Fabris, Chiara Lonati, Vera Gessi, Domenico Rendina, Andrea Dalbeni, Leonardo A. Sechi, Speranza Rubattu, Daniela Merlotti, Lanfranco D'Elia, Andrea Maria Maresca, Massimo Volpe, Patrizia D'Amelio, Andrea Rebellato, Luigi Gennari, Renato Ippolito, Fernando Gianfrancesco |
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| Přispěvatelé: | Rendina, Domenico, Ippolito, Renato, D’Elia, Lanfranco, Giacchetti, Gilberta, Lonati, Chiara, Gianfrancesco, Fernando, Fallo, Francesco, Rebellato, Andrea, Ruggiero, Carmelinda, Rubattu, Speranza, Volpe, Massimo, Gennari, Luigi, Merlotti, Daniela, Isaia, Gian Carlo, D’Amelio, Patrizia, Spertino, Elena, Fabris, Bruno, Sechi, Leonardo A., Catena, Cristiana, Maresca, Andrea M., Gessi, Vera, Dalbeni, Andrea, Strazzullo, Pasquale, D'Elia, Lanfranco |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Time Factors
law.invention Controlled trial Hypertension Hypovitaminosis D Study protocol Vitamin D supplementation Antihypertensive Agents Arterial Pressure Biomarkers Cholecalciferol Clinical Protocols Disease Progression Double-Blind Method Humans Italy Patient Selection Sample Size Treatment Outcome Vitamin D Vitamin D Deficiency Dietary Supplements Internal Medicine Cardiology and Cardiovascular Medicine chemistry.chemical_compound Randomized controlled trial law Medicine Antihypertensive Agent controlled trial hypertension hypovitaminosis D study protocol vitamin D supplementation Human vitamin D3 medicine.medical_specialty Time Factor education vitamin D deficiency Double blind Pharmacotherapy Internal medicine Vitamin D and neurology Clinical Protocol Dietary Supplement Vitamin d supplementation business.industry Biomarker medicine.disease Blood pressure chemistry Physical therapy business |
| Zdroj: | High blood pressure & cardiovascular prevention 22 (2015): 135–142. doi:10.1007/s40292-015-0080-9 info:cnr-pdr/source/autori:Rendina D.; Ippolito R.; D'Elia L.; Giacchetti G.; Lonati C.; Gianfrancesco F.; Fallo F.; Rebellato A.; Ruggiero C.; Rubattu S.; Volpe M.; Gennari L.; Merlotti D.; Isaia G.C.; D'Amelio P.; Spertino E.; Fabris B.; Sechi L.A.; Catena C.; Maresca A.M.; Gessi V.; Dalbeni A.; Strazzullo P./titolo:Hypovitaminosis D and Organ Damage In Patients With Arterial Hypertension: A Multicenter Double Blind Randomised Controlled Trial of Cholecalciferol Supplementation (HYPODD): Study Design, Clinical Procedures and Treatment Protocol/doi:10.1007%2Fs40292-015-0080-9/rivista:High blood pressure & cardiovascular prevention/anno:2015/pagina_da:135/pagina_a:142/intervallo_pagine:135–142/volume:22 |
| DOI: | 10.1007/s40292-015-0080-9 |
| Popis: | Introduction: At this time, good quality randomized clinical trials assessing the effects of vitamin D supplementation on cardiometabolic outcomes are lacking in the international literature. Aim: To fill this gap, the Working Group on Vitamin D and Cardiorenal Disorders established jointly by the Italian Society of Hypertension (SIIA) and the Forum in Bone and Mineral Research conceived the HYPODD study (HYPOvitaminosis D and organ Damage). Methods: HYPODD is a no-profit multicenter 12-month parallel-group double-blind placebo controlled randomized trial aiming to assess the effects of cholecalciferol supplementation on blood pressure control, antihypertensive drugs consumption and progression of target organ damage in patients with essential hypertension and 25-hydroxyvitamin D serum level lower than 20 ng/ml (vitamin D deficiency). HYPODD is coordinated by the European Society Excellence Center of Hypertension of Federico II University, Naples, and involves 12 academic institutions in Italy (Ancona, Milan, Padua, Perugia, Rome, Siena, Trieste, Turin, Udine, Varese, and Verona). Results and conclusion: The HYPODD study has been registered at the Agenzia Italiana del Farmaco-Osservatorio sulla Sperimentazione Clinica del Farmaco (AIFA-OsSC) and EUDRACT sites (n° 2012-003514-14) and has been approved by the Ethical Committees of all the Centers involved in the study. The patients' recruitment is currently underway. |
| Databáze: | OpenAIRE |
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