high dose vitamin-d substitution in patients with covid-19: a randomized controlled, multi center study

Conditions: Covid19; Vitamin D Deficiency; Corona Virus Infection; ARDS; Coronavirus; SARS-CoV Infection

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.

the world is currently experiencing a coronavirus (sars-cov-2) pandemic. the disease caused by infection with this virus is known as covid-19. risk factors for a poor outcome of covid-19 have so far been found to include, older age and co-morbidity including chronic respiratory conditions 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. 25-hydroxyvitamin d supports induction of antimicrobial peptides in response to both viral and bacterial stimuli suggesting a potential mechanism by which vitamin d inducible protection against respiratory pathogens might be mediated. the clear functions of vitamin d in the immune system are difficult to define because the immune response is not a static process. the vitamin-d-receptor, which has also been detected in immunological cells, suggests that vitamin d can regulate some processes related to immunity. a further argument which supports a potential antiviral activity of vitamin d is the modulation of the inflammatory response. the release of pro-inflammatory cytokines by the influenza virus appeared to correlate with the severity of illness. the use of vitamin d as a prophylactic for influenza has shown promise in prevention of illness and reduction of secondary asthma in children. inadequate vitamin d status is associated with susceptibility to upper respiratory infections in patients with chronic obstructive pulmonary disease (copd). in the vidico-trial vitamin d supplementation protected against moderate or severe exacerbation, but not upper respiratory infection, in patients with copd. a further study retrospectively examined data from 108 patients with acute respiratory distress syndrome (ards) for whom a vitamin d status was available at the time of diagnosis revealed that over 95% of these patients had vitamin d deficiency. when examined according to quarterly of serum 25- hydroxyvitamin d, a consistent inverse relationship between serum 25-hydroxyvitamin d and length of hospital and icu stay among survivors was observed. vitamin d substitution in patients with covid-19 who show a vitamin d deficiency should therefore be investigated for efficacy and safety. for this purpose the investigators designed a randomized, placebo controlled double blind trial to test the hypothesis hypothesis that a single high dose of vitamin d in addition to standard treatment improves the recovery period positively in patients with covid-19 and vitamin d deficiency compared to standard treatment only. that means, that the time of recovery is shorter in the single high dose vitamin d group relative to standard treatment group only.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * hospitalized patient * ongoing covid-19 infection * vitamin d deficiency defined as a serum 25-hydroxyvitamin d concentration ≤ 50nmol/l( ≤20ng/ml) * \> 18 years of age exclusion criteria: * known hypersensitivity to one of the used products of vitamin d or indigents in the drug's composition * active malignancy * hypercalcemia * granulomatous disease such as sarcoidosis * history of renal stones within the past year * pregnancy/breastfeeding, as evaluated through screening, * previous enrollment into the current study, * enrollment of the investigator, his/her family members, employees and other dependent persons,

Keywords: covid19 vitamin d deficiency ards corona virus high dose vitamin d