We found a match
Your institution may have rights to this item. Sign in to continue.
- 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
Jaun, Fabienne; Boesing, Maria; Lüthi-Corridori, Giorgia; Abig, Kristin; Makhdoomi, Anja; Bloch, Nando; Lins, Christina; Raess, Andrea; Grillmayr, Victoria; Haas, Philippe; Schuetz, Philipp; Gabutti, Luca; Muser, Jürgen; Leuppi-Taegtmeyer, Anne B.; Giezendanner, Stéphanie; Brändle, Michael; Leuppi, Jörg D.
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>ClinicalTrials.gov NCT04525820 and SNCTP 2020-01401.
- Subjects
COVID-19; VITAMIN D; VITAMIN D deficiency; DIETARY supplements; ADULT respiratory distress syndrome; RESEARCH protocols; RANDOMIZED controlled trials
- Publication
Trials, 2022, Vol 23, Issue 1, p1
- ISSN
1745-6215
- Publication type
Article
- DOI
10.1186/s13063-022-06016-2