High-dose vitamin D substitution in patients with COVID-19: study protocol for a randomized, double-blind, placebo-controlled, multi-center study-VitCov Trial

Fabienne Jaun, Maria Boesing, Giorgia Lüthi-Corridori, Kristin Abig, Anja Makhdoomi, Nando Bloch, Christina Lins, Andrea Raess, Victoria Grillmayr, Philippe Haas, Philipp Schuetz, Luca Gabutti, Jürgen Muser, Anne B Leuppi-Taegtmeyer, Stéphanie Giezendanner, Michael Brändle, Jörg D Leuppi, Fabienne Jaun, Maria Boesing, Giorgia Lüthi-Corridori, Kristin Abig, Anja Makhdoomi, Nando Bloch, Christina Lins, Andrea Raess, Victoria Grillmayr, Philippe Haas, Philipp Schuetz, Luca Gabutti, Jürgen Muser, Anne B Leuppi-Taegtmeyer, Stéphanie Giezendanner, Michael Brändle, Jörg D Leuppi

Abstract

Background: The coronavirus disease 19 (COVID-19) pandemic has caused millions of deaths, and new treatments are urgently needed. Factors associated with a worse COVID-19 prognosis include old age (> 65 years), ethnicity, male sex, obesity, and people with comorbidities. Furthermore, vitamin D deficiency was reported as a predictor of poor prognosis in patients with acute respiratory failure due to COVID-19. According to a recent clinical case series, vitamin D deficiency is a modifiable risk factor, which has the prospect of reducing hospital stay, intensive care, and fatal outcomes. Vitamin D has potent immunomodulatory properties, and its supplementation might improve important outcomes in critically ill and vitamin D-deficient COVID-19 patients. Despite the evidence that supports an association between vitamin D deficiency and COVID-19 severity, there is uncertainty about the direct link. Therefore, the aim of the trial is to assess if high-dose vitamin D supplementation has a therapeutic effect in vitamin D-deficient patients with COVID-19.

Methods: As the trial design, a randomized, placebo-controlled, double-blind, multi-center approach was chosen to compare a high single dose of vitamin D (140,000 IU) followed by treatment as usual (TAU) (VitD + TAU) with treatment as usual only (placebo + TAU) in patients with COVID-19 and vitamin D deficiency.

Discussion: Vitamin D substitution in patients with COVID-19 and vitamin D deficiency should be investigated for efficacy and safety. The study aim is to test the hypothesis that patients with vitamin D deficiency suffering from COVID-19 treated under standardized conditions in hospital will recover faster when additionally treated with high-dose vitamin D supplementation. Latest studies suggest that vitamin D supplementation in patients with COVID-19 is highly recommended to positively influence the course of the disease. With this randomized controlled trial, a contribution to new treatment guidelines shall be made.

Trial registration: ClinicalTrials.gov NCT04525820 and SNCTP 2020-01401.

Keywords: COVID-19; Coronavirus; SARS-CoV-2; Vitamin D; Vitamin D deficiency.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

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