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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04370808
Recruitment Status : Completed
First Posted : May 1, 2020
Last Update Posted : April 28, 2021
Sponsor:
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
Universidade Nova de Lisboa
HeartGenetics, Genetics and Biotechnology SA
Instituto Gulbenkian de Ciência (IGC)
Information provided by (Responsible Party):
Fausto J. Pinto, University of Lisbon

Study Description
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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.

Condition or disease Intervention/treatment
COVID-19 Other: Exposure

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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). ]
  2. 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). ]

Secondary Outcome Measures :
  1. Differences in vitamin D blood levels between COVID-19 patients in relation to mortality. [ Time Frame: Through study completion, an average of 3 months. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]
  6. 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. ]

Eligibility Criteria
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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
Study Population
COVID-19 patients admitted to hospitals from Lisbon and Oporto.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of Lisbon
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
Universidade Nova de Lisboa
HeartGenetics, Genetics and Biotechnology SA
Instituto Gulbenkian de Ciência (IGC)
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fausto J. Pinto, University of Lisbon:
COVID-19
Vitamin D
Vitamin D polymorphisms
Additional relevant MeSH terms:
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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