Trials (Feb 2022)

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

DOI
https://doi.org/10.1186/s13063-022-06016-2
Journal volume & issue
Vol. 23, no. 1
pp. 1 – 11

Abstract

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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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