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

Trials

Study Protocol

Philipp Schuetz¹  Anne B. Leuppi-Taegtmeyer²  Jürgen Muser²  Victoria Grillmayr³  Christina Lins³  Michael Brändle³  Andrea Raess³  Nando Bloch³  Stéphanie Giezendanner⁴  Luca Gabutti⁵  Philippe Haas⁶  Kristin Abig⁷  Giorgia Lüthi-Corridori⁷  Jörg D. Leuppi⁷  Anja Makhdoomi⁷  Maria Boesing⁷  Fabienne Jaun⁷ 

[1] Cantonal Hospital Aarau, Tellstrasse 25, CH-5001, Aarau, Switzerland;Cantonal Hospital Baselland, Rheinstrasse 26, CH-4410, Liestal, Switzerland;Cantonal Hospital St. Gallen, Rohrschacherstrasse 95, CH-9001, St. Gallen, Switzerland;Centre for Primary Health Care, University of Basel, Rheinstrasse 26, CH-4410, Liestal, Switzerland;Regional Hospital Bellinzona, Via A. Gallino 12, CH-6500, Bellinzona, Switzerland;Science Application Concepts GmbH, Luzernerstrasse 190, CH-6402, Merlischachen, Switzerland;University Clinic of Medicine, Cantonal Hospital Baselland, Rheinstrasse 26, CH-4410, Liestal, Switzerland;

关键词: Coronavirus;    SARS-CoV-2;    COVID-19;    Vitamin D;    Vitamin D deficiency;   

DOI  :  10.1186/s13063-022-06016-2

 received in 2020-11-19, accepted in 2022-01-10,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsAs 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.DiscussionVitamin 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 registrationClinicalTrials.gov NCT04525820 and SNCTP 2020-01401

【 授权许可】

CC BY   
© The Author(s). 2022