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 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

Impact of Zinc, Vitamins C and D on Disease Prognosis among Patients with COVID-19 in Bangladesh: A Cross-Sectional Study

“…Further, not taking any medicine, only vitamins and minerals taken as a supplement, was also effectively associated with the reduction in severity (OR: 0.8 (95% CI: 0.3–1.9) ( p = 0.005)) of COVID-19. Findings from this study are in good agreement with previous studies supporting that vitamins and minerals are associated with the improvement of health conditions of COVID-19-infected individuals [ 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 46 , 47 , 48 , 49 ]. Further, a study on the association of vitamin D with a reduced requirement of ICU, oxygen support and death number among hospitalized patients also supports our findings [ 49 ].…”

“…Further, a study on the association of vitamin D with a reduced requirement of ICU, oxygen support and death number among hospitalized patients also supports our findings [ 49 ]. Recent studies on the role of vitamin D against COVID-19 have found various positive impacts [ 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ] including a molecular mechanism of preventing COVID-19 [ 51 ], association with reduced risk of infection [ 45 ], prevention of infection and reduction in the severity of COVID-19 [ 45 , 48 ]. Other studies have found that both vitamin C and Zinc can also contribute to the prevention and treatment of COVID-19 [ 45 , 50 , 51 ].…”

COVID-19 infection and metabolic comorbidities: Mitigating role of nutritional sufficiency and drug – nutraceutical combinations of vitamin D

“…Further they pointed out that larger trials will be required. COVIT and VitCov are recent examples of multicentric controlled clinical trials in France and Switzerland respectively, probing the utility of vitamin D in COVID-19 management [ 170 , 171 ].…”

Vitamin D as a drug: new therapeutic approaches

“…Serum vitamin D concentration is reported to serve as predictor of SARS-CoV-2 infection, which is independent of age, sex, race and attitude (Ilie et al 2020). In comparison to placebo, a single high dose of vitamin D is reported to have an immediate beneficial effect on hospitalized COVID-19 patients in terms of shortening the duration of hospitalization and reducing the need for mechanical ventilation (Jaun et al 2022) Although some progresses have been made in understanding the molecular basis of action of vitamin D, the total picture is not clear. However, enhanced expression of antimicrobial proteins, defensin and cathelicidin which are reported to play important role in the infection outcome process of various bacterial and viral agent (Kearns et al 2015;Fiske et al 2019;Tomaszewska et al 2022) is speculated to have an important role in vitamin D induced protective functions in SARS = CoV-2 infection.…”