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

April 24, 2021 updated by: Fausto J. Pinto, University of Lisbon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

517

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Oporto, Portugal, 4200-319
        • Centro Hospitalar de São João
    • Lisboa
      • Lisbon, Lisboa, Portugal, 1649-032
        • Cardiovascular Center at Universidade de Lisboa
      • Lisbon, Lisboa, Portugal, 1649-032
        • Centro Hospitalar Universitário Lisboa Norte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 patients admitted to hospitals from Lisbon and Oporto.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
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).
Blood samples of COVID-19 patients will be collected at baseline (after subject enrollment; single point collection).

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in vitamin D blood levels between COVID-19 patients in relation to mortality.
Time Frame: Through study completion, an average of 3 months.
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.
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.
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.
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.
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.
Through study completion, an average of 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lisbon

Collaborators

Cardiovascular Centre of Universidade de Lisboa (CCUL)
Faculty of Medicine of Universidade de Lisboa (FMUL)
Centro Hospitalar Universitário Lisboa Norte
Centro Hospitalar Universitário São João (CHUSJ)
CINTESIS - Center for Health Technology and Services Research
NOVA Medical School of Universidade NOVA de Lisboa
HeartGenetics, Genetics and Biotechnology SA
Instituto Gulbenkian de Ciência (IGC)

Investigators

  • 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
  • Principal Investigator: Ana Melo, PhD, BioData.pt/Instituto Gulbenkian Ciência

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

April 26, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 24, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VITACOV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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