Covid19VitCovNCT04525820
High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study
A study testing Single high dose vitamin D and Treatment as usual vitamin D in people with Covid19 and Vitamin D Deficiency, run by Prof. Dr. Jörg Leuppi at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Vitamin D Deficiency, Corona Virus Infection
- What is being tested?
- Single high dose vitamin D and Treatment as usual vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 15 Dec 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Cantonal Hospital Baselland Liestal
Liestal, Basel-Landschaft, 4410
Cantonal Hospital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9001
About this study
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.
Read the detailed description
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.
- Conditions
- Covid19, Vitamin D Deficiency, Corona Virus Infection, ARDS, Coronavirus, SARS-CoV Infection
- Being tested
- Single high dose vitamin D, Placebo, Treatment as usual vitamin D
- Keywords
- Covid19, Vitamin D Deficiency, ARDS, Corona Virus, High dose vitamin D
- Medical subject headings
- COVID-19, Vitamin D Deficiency, Coronavirus Infections, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single high dose vitamin DDrug
Also called VITAMIN D3 oil 500 IU/drop
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
PlaceboDrug
Also called Oily placebo solution
Patient receives a single dose of a placebo solution
Treatment as usual vitamin DDrug
Also called Vitamin D3 solution 4000 IU/ml
Both groups receive the treatment as usual after the single high dose or the placebo which will be 800 IU per day
| Study group | Role | What they receive |
|---|---|---|
| High Dose Vitamin D | Experimental | Patient will receive a single high dose of vitamin D (140'000) in addition to daily 800 IU of vitamin D.
The medication be administered orally Receives: Drug: Single high dose vitamin D; Drug: Treatment as usual vitamin D |
| Placebo | Placebo comparator | Patient will receive a single dose of placebo, orally administered and then treatment as usual (daily 800 IU of vitamin D, orally administered) Receives: Drug: Placebo; Drug: Treatment as usual vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospitalization
Overall duration of the hospitalization from day of admission until the day of discharge or fatality
Measured: Administration to Discharge from hospital care (mean duration is between 14 and 22 days for Patients with COVID 19)
Secondary outcomes (5)
Need of intensive care
Did the patient need a intensive care treatment during the hospitalization (yes/no)
Measured: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)
Lenght of the Intensive Care Treatment
Day of admission to ICU until discharge or fatality
Measured: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)
Overall mortality
Percentage of patient died during hospitalization
Measured: During the length of hospitalisation (mean duration is between 14 and 22 days for Patients with COVID-19)
Development of vitamin D levels
percentage of patients with 25-hydroxyvitamin D > 50nmol/L (>20ng/mL) at day 7
- The values of calcium, phosphorus, 24-hydroxyvitamin D, 1.25-dihydroxyvitamin D, parathyroid hormone.
Measured: Day 1 (Baseline) and Day 7 after the first administration of the high dose vitamin D or the placebo and at discharge (mean hospital stay is between 14 and 22 days for Patients with COVID-19)
Development of sepsis
percentage of patients developing a sepsis
Measured: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start15 Dec 2020
- Primary completion30 Aug 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group receives a single high dose of vitamin D in addition to treatment as usual (TAU) the other group receives a single dose of placebo in addition to TAU
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Jörg Leuppi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Jörg Leuppi, Cantonal Hospital, Baselland
- Investigators
- Jörg D Leuppi, Professor, Study director, Cantonal Hospital, Baselland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525820
- Sponsor's protocol ID
- 2020-01401
- Acronym
- VitCov
- Status last verified
- Feb 2023
- First submitted
- 17 Aug 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaun F, Boesing M, Luthi-Corridori G, Abig K, Makhdoomi A, Bloch N, Lins C, Raess A, Grillmayr V, Haas P, Schuetz P, Gabutti L, Muser J, Leuppi-Taegtmeyer AB, Giezendanner S, Brandle M, Leuppi JD. High-dose vitamin D substitution in patients with COVID-19: study protocol for a randomized, double-blind, placebo-controlled, multi-center study-VitCov Trial. Trials. 2022 Feb 4;23(1):114. doi: 10.1186/s13063-022-06016-2.
PubMed 35120577
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study
- ClinicalTrials.gov ID
- NCT04525820
- Acronym / sponsor ID
- VitCov / 2020-01401
- Conditions
- Covid19, Vitamin D Deficiency, Corona Virus Infection, ARDS, Coronavirus, SARS-CoV Infection
- Keywords
- Covid19, Vitamin D Deficiency, ARDS, Corona Virus, High dose vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Prof. Dr. Jörg LeuppiUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- one group receives a single high dose of vitamin D in addition to treatment as usual (TAU) the other group receives a single dose of placebo in addition to TAU
| Arm | Type | Receives |
|---|---|---|
| High Dose Vitamin D | Experimental | Drug: Single high dose vitamin D, Drug: Treatment as usual vitamin DPatient will receive a single high dose of vitamin D (140'000) in addition to daily 800 IU of vitamin D. The medication be administered orally |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Treatment as usual vitamin DPatient will receive a single dose of placebo, orally administered and then treatment as usual (daily 800 IU of vitamin D, orally administered) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single high dose vitamin DAlso: VITAMIN D3 oil 500 IU/dropPatient 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 | Drug | High Dose Vitamin D |
| PlaceboAlso: Oily placebo solutionPatient receives a single dose of a placebo solution | Drug | Placebo |
| Treatment as usual vitamin DAlso: Vitamin D3 solution 4000 IU/mlBoth groups receive the treatment as usual after the single high dose or the placebo which will be 800 IU per day | Drug | High Dose Vitamin D, Placebo |
Primary outcome
Length of hospitalization
Time frame: Administration to Discharge from hospital care (mean duration is between 14 and 22 days for Patients with COVID 19)
Overall duration of the hospitalization from day of admission until the day of discharge or fatality
5 secondary outcomes
Need of intensive care
Time frame: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)
Lenght of the Intensive Care Treatment
Time frame: Until discharge or fatality (mean duration is between 14 and 22 days for Patients with COVID-19)
Overall mortality
Time frame: During the length of hospitalisation (mean duration is between 14 and 22 days for Patients with COVID-19)
Development of vitamin D levels
Time frame: Day 1 (Baseline) and Day 7 after the first administration of the high dose vitamin D or the placebo and at discharge (mean hospital stay is between 14 and 22 days for Patients with COVID-19)
Development of sepsis
Time frame: During the length of hospitalization (mean duration is between 14 and 22 days for Patients with COVID-19)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 35120577Jaun F, Boesing M, Luthi-Corridori G, Abig K, Makhdoomi A, Bloch N, Lins C, Raess A, Grillmayr V, Haas P, Schuetz P, Gabutti L, Muser J, Leuppi-Taegtmeyer AB, Giezendanner S, Brandle M, Leuppi JD. High-dose vitamin D substitution in patients with COVID-19: study protocol for a randomized, double-blind, placebo-controlled, multi-center study-VitCov Trial. Trials. 2022 Feb 4;23(1):114. doi: 10.1186/s13063-022-06016-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg D Leuppi, Professor study director
Cantonal Hospital, Baselland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single high dose vitamin D and Treatment as usual vitamin D in people with Covid19 and Vitamin D Deficiency, run by Prof. Dr. Jörg Leuppi at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospitalization (time frame: Administration to Discharge from hospital care (mean duration is between 14 and 22 days for Patients with COVID 19)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04525820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.