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Open Access 01-12-2022 | Coronavirus | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2022

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

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Title: High-dose vitamin D substitution in patients with COVID-19: study protocol for a randomized, double-blind, placebo-controlled, multi-center study—VitCov Trial
Authors: 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
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Coronavirus
Vitamin D Deficiency
COVID-19
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06016-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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