VITACOV: Vitamin D Polymorphisms and Severity of COVID-19 Infection (VITACOV)
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ClinicalTrials.gov Identifier: NCT04370808 |
Recruitment Status :
Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : May 19, 2020
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Condition or disease | Intervention/treatment |
---|---|
COVID-19 | Other: Exposure |
Study Type : | Observational |
Estimated Enrollment : | 500 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 |
Estimated Study Start Date : | June 2020 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | March 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
Contact: Fausto J Pinto, PhD | 00351217985113 | faustopinto@medicina.ulisboa.pt | |
Contact: Conceição Calhau, PhD | 00351218803035 ext 20401 | ccalhau@nms.unl.pt |
Portugal | |
Cardiovascular Center at Universidade de Lisboa | |
Lisbon, Lisboa, Portugal, 1649-032 | |
Contact: Fausto J Pinto, PhD 00351217985113 faustopinto@medicina.ulisboa.pt | |
Contact: Fátima Casaca, BSc 00351210008500 CCUL@medicina.ulisboa.pt | |
Centro Hospitalar Universitário Lisboa Norte | |
Lisbon, Lisboa, Portugal, 1649-032 | |
Contact: Fausto Pinto, PhD 00351217985113 faustopinto@medicina.ulisboa.pt | |
Sub-Investigator: Melo Cristino, PhD | |
Sub-Investigator: Ana Miranda, MD | |
Sub-Investigator: Helena Proença, MD | |
Principal Investigator: Fausto J Pinto, PhD | |
Centro Hospitalar de São João | |
Oporto, Portugal, 4200-319 | |
Contact: Tiago Guimarães, PhD jtguimar@med.up.pt | |
Principal Investigator: Tiago Guimarães, PhD |
Principal Investigator: | Fausto J Pinto, PhD | Faculty of Medicine of Universidade de Lisboa | |
Principal Investigator: | Conceição Calhau, PhD | NOVA Medical School of Universidade NOVA de Lisboa | |
Principal Investigator: | Ana Freitas, PhD | HeartGenetics SA | |
Principal Investigator: | Tiago Guimarães, PhD | Faculty of Medicine of the University of Porto |
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: | May 19, 2020 |
Last Verified: | May 2020 |
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 |
Infection |