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VITACOV: Vitamin D Polymorphisms and Severity of COVID-19 Infection

VITACOV: Vitamin D-related Polymorphisms and Vitamin D Levels as Risk Biomarkers of COVID-19 Infection Severity

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04370808
Acronym
VITACOV
Enrollment
517
Registered
2020-05-01
Start date
2020-08-01
Completion date
2021-01-31
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, Vitamin D, Vitamin D polymorphisms

Brief 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). 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.

Interventions

OTHERExposure

Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.

Sponsors

Cardiovascular Centre of Universidade de Lisboa (CCUL)
CollaboratorUNKNOWN
Faculty of Medicine of Universidade de Lisboa (FMUL)
CollaboratorUNKNOWN
Centro Hospitalar Universitário Lisboa Norte
CollaboratorOTHER
Centro Hospitalar Universitário São João (CHUSJ)
CollaboratorUNKNOWN
CINTESIS - Center for Health Technology and Services Research
CollaboratorUNKNOWN
Universidade Nova de Lisboa
CollaboratorOTHER
HeartGenetics, Genetics and Biotechnology SA
CollaboratorINDUSTRY
Instituto Gulbenkian de Ciência (IGC)
CollaboratorUNKNOWN
University of Lisbon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Differences in vitamin D blood levels between COVID-19 patients with different degrees of disease severity.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.Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).

Secondary

MeasureTime frame
Differences in vitamin D blood levels between COVID-19 patients in relation to duration of mechanical ventilation.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.Through study completion, an average of 3 months.
Differences in vitamin D blood levels between COVID-19 patients in relation to mortality.Through study completion, an average of 3 months.
Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to duration of mechanical ventilation.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.Through study completion, an average of 1 year.
Differences in vitamin D blood levels between COVID-19 patients in relation to length of stay in hospitals.Through study completion, an average of 3 months.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026