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

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.

• Authors: Domenico Rendina, Renato Ippolito, Lanfranco D'Elia, Gilberta Giacchetti, Chiara Lonati, Fernando Gianfrancesco, Francesco Fallo, Andrea Rebellato, Carmelinda Ruggiero, Speranza Rubattu, Massimo Volpe, Luigi Gennari, Daniela Merlotti, Gian Carlo Isaia, Patrizia D'Amelio, Elena Spertino, Bruno Fabris, Leonardo A Sechi, Cristiana Catena, Andrea M Maresca, Vera Gessi, Andrea Dalbeni, Pasquale Strazzullo
• Journal: High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension (High Blood Press Cardiovasc Prev) Vol. 22 Issue 2 Pg. 135-42 (Jun 2015) ISSN: 1179-1985 [Electronic] New Zealand
• PMID: 25771895 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antihypertensive Agents
• Biomarkers
• Vitamin D
• Cholecalciferol
• 25-hydroxyvitamin D

Topics

• Antihypertensive Agents (therapeutic use)
• Arterial Pressure (drug effects)
• Biomarkers (blood)
• Cholecalciferol (therapeutic use)
• Clinical Protocols
• Dietary Supplements
• Disease Progression
• Double-Blind Method
• Humans
• Hypertension (complications, diagnosis, drug therapy, physiopathology)
• Italy
• Patient Selection
• Sample Size
• Time Factors
• Treatment Outcome
• Vitamin D (analogs & derivatives, blood)
• Vitamin D Deficiency (blood, complications, diagnosis, drug therapy)