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

NCT04370808 | Completed

• 1 other identifier: VITACOV
• Study Type: observational
• Target: 517
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Keywords

COVID-19; Vitamin D; Vitamin D polymorphisms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Differences in vitamin D blood levels 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 length of stay in hospitals.

  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.

  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 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.

Study Arms (2)

Mild to severe disease

Mild to severe disease (admission to isolation room)

Other: Exposure

Critical patients

Critical patients (admission to ICU)

Other: Exposure

Interventions

Exposure OTHER

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

Critical patients; Mild to severe disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients diagnosed with COVID-19 not admitted to hospital.
• Patients unable to provide informed consent.

Sponsors & Collaborators

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

Study Sites (3)

Cardiovascular Center at Universidade de Lisboa

Lisbon, Lisbon District, 1649-032, Portugal

Location

Centro Hospitalar Universitário Lisboa Norte

Lisbon, Lisbon District, 1649-032, Portugal

Location

Centro Hospitalar de São João

Porto, 4200-319, Portugal

Location

Related Publications (1)

• 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.

  PMID: 34675344 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: May 1, 2020
• Study Start: August 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 31, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

PT (3)