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NCT Number: NCT04370808

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

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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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Center at Universidade de Lisboa, Lisbon, Lisbon District, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exposure

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Lisbon

Other

Collaborators

  • CINTESIS - Center for Health Technology and Services Research
  • Cardiovascular Centre of Universidade de Lisboa (CCUL)
  • Centro Hospitalar De São João, E.P.E.
  • Centro Hospitalar Universitário Lisboa Norte
  • Faculty of Medicine of Universidade de Lisboa (FMUL)
  • HeartGenetics, Genetics and Biotechnology SA
  • Instituto Gulbenkian de Ciência (IGC)
  • Universidade Nova de Lisboa

Registry information

Official study title

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

Acronym: VITACOV

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 1, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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