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

NCT ID: NCT04370808

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

517 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-01-31

Brief Summary

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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.

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Detailed Description

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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

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COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Mild to severe disease

Mild to severe disease (admission to isolation room)

Exposure

Intervention Type OTHER

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

Critical patients

Critical patients (admission to ICU)

Exposure

Intervention Type OTHER

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

Interventions

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Exposure

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiovascular Centre of Universidade de Lisboa (CCUL)

UNKNOWN

Sponsor Role collaborator

Faculty of Medicine of Universidade de Lisboa (FMUL)

UNKNOWN

Sponsor Role collaborator

Centro Hospitalar Universitário Lisboa Norte

OTHER

Sponsor Role collaborator

Centro Hospitalar Universitário São João (CHUSJ)

UNKNOWN

Sponsor Role collaborator

CINTESIS - Center for Health Technology and Services Research

UNKNOWN

Sponsor Role collaborator

Universidade Nova de Lisboa

OTHER

Sponsor Role collaborator

HeartGenetics, Genetics and Biotechnology SA

INDUSTRY

Sponsor Role collaborator

Instituto Gulbenkian de Ciência (IGC)

UNKNOWN

Sponsor Role collaborator

University of Lisbon

OTHER

Sponsor Role lead

Responsible Party

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Fausto J. Pinto

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fausto J Pinto, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine of Universidade de Lisboa

Conceição Calhau, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Nova de Lisboa

Ana Freitas, PhD

Role: PRINCIPAL_INVESTIGATOR

HeartGenetics SA

Tiago Guimarães, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine of the University of Porto

Ana Melo, PhD

Role: PRINCIPAL_INVESTIGATOR

BioData.pt/Instituto Gulbenkian Ciência

Locations

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Cardiovascular Center at Universidade de Lisboa

Lisbon, Lisbon District, Portugal

Site Status

Centro Hospitalar Universitário Lisboa Norte

Lisbon, Lisbon District, Portugal

Site Status

Centro Hospitalar de São João

Porto, , Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type DERIVED
PMID: 34675344 (View on PubMed)

Other Identifiers

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VITACOV

Identifier Type: -

Identifier Source: org_study_id

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