drugset / Trial / NCT04525820

High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study

NCT04525820

Completed 80 enrolled Prof. Dr. Jörg Leuppi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The world is currently facing a pandemic with the coronavirus (SARS-CoV-2) which leads to the disease of COVID-19. Risk factors for a poor outcome of COVID-19 have so far been identified as older age and co-morbidity including chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and current smoking status. Previous studies found, that vitamin D deficiency is more prevalent among patients with these risk factors. There are observational studies reporting independent associations between low serum concentrations of 25-hydroxyvitamin D (the major circulating vitamin D metabolite) and susceptibility to acute respiratory tract infection. Vitamin D substitution in patients with COVID-19 who show a vitamin D deficiency should therefore be investigated for efficacy and safety. The study is designed as a randomized, placebo-controlled, double blind study. 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 a single high dose of vitamin D compared to standard treatment only.

Timeline

Start
2020-12-15
Primary completion
2021-08-30
Completion
2021-11-30

Drugs

EvaluationDrugModalityDoseRoute
Background Vitamin D Other / unclassified 140000 iu Oral
Background Vitamin D Other / unclassified 800 iu Oral