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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.

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Correspondence to Pasquale Strazzullo.

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Rendina, D., Ippolito, R., D’Elia, L. et al. Hypovitaminosis D and Organ Damage In Patients With Arterial Hypertension: A Multicenter Double Blind Randomised Controlled Trial of Cholecalciferol Supplementation (HYPODD). High Blood Press Cardiovasc Prev 22, 135–142 (2015). https://doi.org/10.1007/s40292-015-0080-9

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Keywords

  • Study protocol
  • Controlled trial
  • Hypovitaminosis D
  • Vitamin D supplementation
  • Hypertension