1. 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.
- Author
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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 GC, D'Amelio P, Spertino E, Fabris B, Sechi LA, Catena C, Maresca AM, Gessi V, Dalbeni A, and Strazzullo P
- Subjects
- Biomarkers blood, Clinical Protocols, Disease Progression, Double-Blind Method, Humans, Hypertension complications, Hypertension diagnosis, Hypertension physiopathology, Italy, Patient Selection, Sample Size, Time Factors, Treatment Outcome, Vitamin D analogs & derivatives, Vitamin D blood, Vitamin D Deficiency blood, Vitamin D Deficiency complications, Vitamin D Deficiency diagnosis, Antihypertensive Agents therapeutic use, Arterial Pressure drug effects, Cholecalciferol therapeutic use, Dietary Supplements, Hypertension drug therapy, Vitamin D Deficiency drug therapy
- Abstract
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.
- Published
- 2015
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