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.
Drug: Single high dose vitamin D
Patient receives either one dose orally of 140'000 IU (7 ml) of this drug once as an intervention treatment additionally to TAU or the patient receives 7 ml of the placebo Solution (7 ml) in addition to TAU
Other Name: VITAMIN D3 oil 500 IU/drop
Drug: Placebo
Patient receives a single dose of a placebo solution
Other Name: Oily placebo solution
Drug: Treatment as usual vitamin D
Both groups receive the treatment as usual after the single high dose or the placebo which will be 800 IU per day
Other Name: Vitamin D3 solution 4000 IU/ml
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,
Cantonal Hospital Baselland Liestal
Liestal, BL, Switzerland
Cantonal Hospital St. Gallen
Saint Gallen, SG, Switzerland
Jörg D Leuppi, Professor, Study Director
Cantonal Hosptal, Baselland