COVID-19VITACOVNCT04370808
VITACOV: Vitamin D Polymorphisms and Severity of COVID-19 Infection
An observational study of COVID-19, run by University of Lisbon at 3 sites in Portugal.
Trial summary
Vitamin D deficiency has been linked to hypertension, autoimmune, infectious and cardiovascular diseases which are risk factors for COVID-19. Moreover, COVID-19 patients have a very high prevalence of hypovitaminosis D (Turin data). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Exposure
- How many people
- 517 participants
- Where
- 3 sitesPortugal
- Study dates
- 1 Aug 2020to 31 Jan 2021
- Phase
- Observational
- 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
Study population: COVID-19 patients admitted to hospitals from Lisbon and Oporto.
Who may be able to join
- Adults of 18 years and above.
- COVID-19 patients admitted with mild to severe disease (admission to isolation room) or critical patients (admission to ICU).
- Available to comply with study protocol and sign informed consent.
Who cannot join
- Patients diagnosed with COVID-19 not admitted to hospital.
- Patients unable to provide informed consent.
Trial locations and contacts
3 sites in 1 country.
Portugal3 sites
Cardiovascular Center at Universidade de Lisboa
Lisbon, Lisbon District, 1649-032
Centro Hospitalar Universitário Lisboa Norte
Lisbon, Lisbon District, 1649-032
Centro Hospitalar de São João
Porto, 4200-319
About this study
Official title: VITACOV: Vitamin D-related Polymorphisms and Vitamin D Levels as Risk Biomarkers of COVID-19 Infection Severity
Vitamin D deficiency has been linked to hypertension, autoimmune, infectious and cardiovascular diseases which are risk factors for COVID-19. Moreover, COVID-19 patients have a very high prevalence of hypovitaminosis D (Turin data). Taken together, we aim to investigate whether genetic variants in vitamin D-related genes contribute to a poor COVID-19 outcome, particularly in hypertension and CV patients, proposing thus a personalized therapeutics based on vitamin D supplementation in order to reduce the severity and deaths.
Read the detailed description
Collected data from Turin University indicate that hospitalized patients have a very high prevalence of hypovitaminosis D. Reports from China and Italy show that hypertension presents an increased risk of COVID-19-related death. Otherwise, observational studies suggest that 25(OH)D induces protection against respiratory pathogens while large-scale studies indicate that serum 25(OH)D-level is inversely correlated to hypertension prevalence. Recent published data (2020) shows that 66% of Portuguese adults present Vitamin D deficiency. HeartGenetics' genetic database with more than 8.500 Portuguese genotypes shows that the prevalence of vitamin D polymorphisms in this population is 4-fold higher than the EU average, increasing the risk of hypovitaminosis D.
- Conditions
- COVID-19
- Being tested
- Exposure
- Keywords
- COVID-19, Vitamin D, Vitamin D polymorphisms
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposureOther
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Mild to severe disease | Mild to severe disease (admission to isolation room) Receives: Other: Exposure | |
| Critical patients | Critical patients (admission to ICU) Receives: Other: Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in vitamin D blood levels between COVID-19 patients with different degrees of disease severity.
Measured: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).
Differences in genetic variants in vitamin D-related genes between COVID-19 patients with different degrees of disease severity.
Measured: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).
Secondary outcomes (6)
Differences in vitamin D blood levels between COVID-19 patients in relation to mortality.
Measured: Through study completion, an average of 3 months.
Differences in vitamin D blood levels between COVID-19 patients in relation to length of stay in hospitals.
Measured: Through study completion, an average of 3 months.
Differences in vitamin D blood levels between COVID-19 patients in relation to duration of mechanical ventilation.
Measured: Through study completion, an average of 3 months.
Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to mortality.
Measured: Through study completion, an average of 3 months.
Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to length of stay in hospitals.
Measured: Through study completion, an average of 1 year.
Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to duration of mechanical ventilation.
Measured: Through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Aug 2020
- Primary completion1 Jan 2021
- Study completion31 Jan 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 COVID-19Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiovascular Centre of Universidade de Lisboa (CCUL), Faculty of Medicine of Universidade de Lisboa (FMUL), Centro Hospitalar Universitário Lisboa Norte, Centro Hospitalar De São João, E.P.E., Center for Health Technology and Services Research, Universidade Nova de Lisboa, HeartGenetics, Genetics and Biotechnology SA, Instituto Gulbenkian de Ciência (IGC)
- Responsible party
- Principal investigator, Fausto J. Pinto, University of Lisbon
- Investigators
- Fausto J Pinto, PhD, Principal investigator, Faculty of Medicine of Universidade de LisboaConceição Calhau, PhD, Principal investigator, Universidade Nova de LisboaAna Freitas, PhD, Principal investigator, HeartGenetics SATiago Guimarães, PhD, Principal investigator, Universidade do PortoAna Melo, PhD, Principal investigator, BioData.pt/Instituto Gulbenkian Ciência
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370808
- Sponsor's protocol ID
- VITACOV
- Acronym
- VITACOV
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Freitas AT, Calhau C, Antunes G, Araujo B, Bandeira M, Barreira S, Bazenga F, Braz S, Caldeira D, Santos SCR, Faria A, Faria D, Fraga M, Nogueira-Garcia B, Goncalves L, Kovalchuk P, Lacerda L, Lopes H, Luis D, Medeiros F, Melo AMP, Melo-Cristino J, Miranda A, Pereira C, Pinto AT, Pinto J, Proenca H, Ramos A, Rato JPR, Rocha F, Rocha JC, Moreira-Rosario A, Vazao H, Volovetska Y, Guimaraes JT, Pinto FJ. Vitamin D-related polymorphisms and vitamin D levels as risk biomarkers of COVID-19 disease severity. Sci Rep. 2021 Oct 21;11(1):20837. doi: 10.1038/s41598-021-99952-z.
PubMed 34675344
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITACOV: Vitamin D-related Polymorphisms and Vitamin D Levels as Risk Biomarkers of COVID-19 Infection Severity
- ClinicalTrials.gov ID
- NCT04370808
- Acronym / sponsor ID
- VITACOV / VITACOV
- Conditions
- COVID-19
- Keywords
- COVID-19, Vitamin D, Vitamin D polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Collaborators
- Cardiovascular Centre of Universidade de Lisboa (CCUL), Faculty of Medicine of Universidade de Lisboa (FMUL), Centro Hospitalar Universitário Lisboa Norte, Centro Hospitalar De São João, E.P.E., Center for Health Technology and Services Research, Universidade Nova de Lisboa, HeartGenetics, Genetics and Biotechnology SA, Instituto Gulbenkian de Ciência (IGC)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 1 May 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.
Vitamin D deficiency has been linked to hypertension, autoimmune, infectious and cardiovascular diseases which are risk factors for COVID-19. Moreover, COVID-19 patients have a very high prevalence of hypovitaminosis D (Turin data). Taken together, we aim to investigate whether genetic variants in vitamin D-related genes contribute to a poor COVID-19 outcome, particularly in hypertension and CV patients, proposing thus a personalized therapeutics based on vitamin D supplementation in order to reduce the severity and deaths.
Detailed description
Collected data from Turin University indicate that hospitalized patients have a very high prevalence of hypovitaminosis D. Reports from China and Italy show that hypertension presents an increased risk of COVID-19-related death. Otherwise, observational studies suggest that 25(OH)D induces protection against respiratory pathogens while large-scale studies indicate that serum 25(OH)D-level is inversely correlated to hypertension prevalence. Recent published data (2020) shows that 66% of Portuguese adults present Vitamin D deficiency. HeartGenetics' genetic database with more than 8.500 Portuguese genotypes shows that the prevalence of vitamin D polymorphisms in this population is 4-fold higher than the EU average, increasing the risk of hypovitaminosis D.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild to severe disease | – | Other: ExposureMild to severe disease (admission to isolation room) |
| Critical patients | – | Other: ExposureCritical patients (admission to ICU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients admitted to hospitals from Lisbon and Oporto.
Key inclusion criteria (3 listed)
- Adults of 18 years and above.
- COVID-19 patients admitted with mild to severe disease (admission to isolation room) or critical patients (admission to ICU).
- Available to comply with study protocol and sign informed consent.
Key exclusion criteria (2 listed)
- Patients diagnosed with COVID-19 not admitted to hospital.
- Patients unable to provide informed consent.
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 |
|---|---|---|
| ExposureIndividuals with SARS-CoV-2 exposure and COVID-19 symptoms. | Other | Critical patients, Mild to severe disease |
Primary outcome
Differences in vitamin D blood levels between COVID-19 patients with different degrees of disease severity.
Time frame: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).
Differences in genetic variants in vitamin D-related genes between COVID-19 patients with different degrees of disease severity.
Time frame: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).
6 secondary outcomes
Differences in vitamin D blood levels between COVID-19 patients in relation to mortality.
Time frame: Through study completion, an average of 3 months.
Differences in vitamin D blood levels between COVID-19 patients in relation to length of stay in hospitals.
Time frame: Through study completion, an average of 3 months.
Differences in vitamin D blood levels between COVID-19 patients in relation to duration of mechanical ventilation.
Time frame: Through study completion, an average of 3 months.
Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to mortality.
Time frame: Through study completion, an average of 3 months.
Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to length of stay in hospitals.
Time frame: Through study completion, an average of 1 year.
Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to duration of mechanical ventilation.
Time frame: Through study completion, an average of 3 months.
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 28 Apr 2021.
- Derived from this study: PubMed 34675344Freitas AT, Calhau C, Antunes G, Araujo B, Bandeira M, Barreira S, Bazenga F, Braz S, Caldeira D, Santos SCR, Faria A, Faria D, Fraga M, Nogueira-Garcia B, Goncalves L, Kovalchuk P, Lacerda L, Lopes H, Luis D, Medeiros F, Melo AMP, Melo-Cristino J, Miranda A, Pereira C, Pinto AT, Pinto J, Proenca H, Ramos A, Rato JPR, Rocha F, Rocha JC, Moreira-Rosario A, Vazao H, Volovetska Y, Guimaraes JT, Pinto FJ. Vitamin D-related polymorphisms and vitamin D levels as risk biomarkers of COVID-19 disease severity. Sci Rep. 2021 Oct 21;11(1):20837. doi: 10.1038/s41598-021-99952-z.
- Individual participant dataSharing planned: Undecided
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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.
Fausto J Pinto, PhD principal investigator
Faculty of Medicine of Universidade de Lisboa
Conceição Calhau, PhD principal investigator
Universidade Nova de Lisboa
Ana Freitas, PhD principal investigator
HeartGenetics SA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University of Lisbon at 3 sites in Portugal.
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 3 inclusion and 2 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal. 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. 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?
Differences in vitamin D blood levels between COVID-19 patients with different degrees of disease severity. (time frame: Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).). The study lists 2 primary outcomes in all. 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 NCT04370808, 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 28 Apr 2021.