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

COVID-19 Clinical Trial

— VITACOV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370808
• Other study ID #: VITACOV
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2021
• Source: University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: January 31, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

Other:
• Exposure
Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.

Locations

Country	Name	City	State
Portugal	Cardiovascular Center at Universidade de Lisboa	Lisbon	Lisboa
Portugal	Centro Hospitalar Universitário Lisboa Norte	Lisbon	Lisboa
Portugal	Centro Hospitalar de São João	Oporto

Sponsors (9)

Lead Sponsor

Collaborator

University of Lisbon

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

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	Differences in vitamin D blood levels between COVID-19 patients in relation to mortality.		Through study completion, an average of 3 months.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Differences in genetic variants in vitamin D-related genes between COVID-19 patients in relation to duration of mechanical ventilation.		Through study completion, an average of 3 months.