title: 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.
abstract: BACKGROUND
  At this time, good quality randomized clinical trials assessing the effects of vitamin D supplementation on cardiometabolic outcomes are lacking in the international literature.
  
  
  OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Clinical Medicine and Surgery, Excellence Center of Hypertension, ''Federico II University'' Medical School, via Sergio Pansini 5, 80131, Naples, Italy, domenico.rendina@unina.it.
authors.forename: Domenico
authors.initials: D
authors.lastname: Rendina
authors.forename: Renato
authors.initials: R
authors.lastname: Ippolito
authors.forename: Lanfranco
authors.initials: L
authors.lastname: D'Elia
authors.forename: Gilberta
authors.initials: G
authors.lastname: Giacchetti
authors.forename: Chiara
authors.initials: C
authors.lastname: Lonati
authors.forename: Fernando
authors.initials: F
authors.lastname: Gianfrancesco
authors.forename: Francesco
authors.initials: F
authors.lastname: Fallo
authors.forename: Andrea
authors.initials: A
authors.lastname: Rebellato
authors.forename: Carmelinda
authors.initials: C
authors.lastname: Ruggiero
authors.forename: Speranza
authors.initials: S
authors.lastname: Rubattu
authors.forename: Massimo
authors.initials: M
authors.lastname: Volpe
authors.forename: Luigi
authors.initials: L
authors.lastname: Gennari
authors.forename: Daniela
authors.initials: D
authors.lastname: Merlotti
authors.forename: Gian Carlo
authors.initials: GC
authors.lastname: Isaia
authors.forename: Patrizia
authors.initials: P
authors.lastname: D'Amelio
authors.forename: Elena
authors.initials: E
authors.lastname: Spertino
authors.forename: Bruno
authors.initials: B
authors.lastname: Fabris
authors.forename: Leonardo A
authors.initials: LA
authors.lastname: Sechi
authors.forename: Cristiana
authors.initials: C
authors.lastname: Catena
authors.forename: Andrea M
authors.initials: AM
authors.lastname: Maresca
authors.forename: Vera
authors.initials: V
authors.lastname: Gessi
authors.forename: Andrea
authors.initials: A
authors.lastname: Dalbeni
authors.forename: Pasquale
authors.initials: P
authors.lastname: Strazzullo
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use*; D062186:Arterial Pressure / Q000187:drug effects*; D015415:Biomarkers / Q000097:blood; D002762:Cholecalciferol / Q000627:therapeutic use*; D002985:Clinical Protocols; D019587:Dietary Supplements; D018450:Disease Progression; D004311:Double-Blind Method; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D007558:Italy; D018579:Patient Selection; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*
chemical_list: D000959:Antihypertensive Agents; D015415:Biomarkers; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D