Abstract
BackgroundThe Coronavirus disease 19 (Covid-19) pandemic has caused more than a million 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 such as hypertension, diabetes, cardiovascular disease, and respiratory diseases. Further, vitamin D deficiency has been reported to be a predictor of poor prognosis in patients with acute respiratory failure due to Covid-19. Vitamin D deficiency is a modifiable risk factor, which - according to a recent clinical case series – has the prospect of reducing hospital stay, intensive care and fatal outcomes. Vitamin D has potent immunomodulatory property sand 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. The aim of the trial is therefore to assess if high dose vitamin D supplementation has a therapeutic effect in vitamin D deficient patients with Covid-19.MethodsRandomized, placebo-controlled double blind, multi-centre study trial 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 objective of the study 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 randomised controlled trial, a contribution to new treatment guidelines shall be made.Trial registration: clinicaltrials.gov: NCT04525820 and SNCTP: 2020 − 01401
Incidence of Hypocalcemic Seizures Due to Vitamin D Deficiency in Children in the United Kingdom and Ireland
