VITACOV: Vitamin D Polymorphisms and Severity of COVID-19 Infection (VITACOV)
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ClinicalTrials.gov Identifier: NCT04370808 |
Recruitment Status :
Completed
First Posted : May 1, 2020
Last Update Posted : April 28, 2021
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Condition or disease | Intervention/treatment |
---|---|
COVID-19 | Other: Exposure |
Study Type : | Observational |
Actual Enrollment : | 517 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | VITACOV: Vitamin D-related Polymorphisms and Vitamin D Levels as Risk Biomarkers of COVID-19 Infection Severity |
Actual Study Start Date : | August 1, 2020 |
Actual Primary Completion Date : | January 1, 2021 |
Actual Study Completion Date : | January 31, 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Mild to severe disease
Mild to severe disease (admission to isolation room)
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Other: Exposure
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms. |
Critical patients
Critical patients (admission to ICU)
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Other: Exposure
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms. |
- 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). ]
- 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. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients diagnosed with COVID-19 not admitted to hospital.
- Patients unable to provide informed consent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370808
Portugal | |
Cardiovascular Center at Universidade de Lisboa | |
Lisbon, Lisboa, Portugal, 1649-032 | |
Centro Hospitalar Universitário Lisboa Norte | |
Lisbon, Lisboa, Portugal, 1649-032 | |
Centro Hospitalar de São João | |
Oporto, Portugal, 4200-319 |
Principal Investigator: | Fausto J Pinto, PhD | Faculty of Medicine of Universidade de Lisboa | |
Principal Investigator: | Conceição Calhau, PhD | Universidade Nova de Lisboa | |
Principal Investigator: | Ana Freitas, PhD | HeartGenetics SA | |
Principal Investigator: | Tiago Guimarães, PhD | Faculty of Medicine of the University of Porto | |
Principal Investigator: | Ana Melo, PhD | BioData.pt/Instituto Gulbenkian Ciência |
Responsible Party: | Fausto J. Pinto, Professor, University of Lisbon |
ClinicalTrials.gov Identifier: | NCT04370808 |
Other Study ID Numbers: |
VITACOV |
First Posted: | May 1, 2020 Key Record Dates |
Last Update Posted: | April 28, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Vitamin D Vitamin D polymorphisms |
COVID-19 Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |