VITACOV: Vitamin D Polymorphisms and Severity of COVID-19 Infection
- Conditions
- COVID-19
- Interventions
- Other: Exposure
- Registration Number
- NCT04370808
- Lead Sponsor
- University of Lisbon
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 517
- 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.
- Patients diagnosed with COVID-19 not admitted to hospital.
- Patients unable to provide informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Critical patients Exposure Critical patients (admission to ICU) Mild to severe disease Exposure Mild to severe disease (admission to isolation room)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 length of stay in hospitals. 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. Through study completion, an average of 3 months. 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 genetic variants in vitamin D-related genes between COVID-19 patients in relation to mortality. Through study completion, an average of 3 months.
Trial Locations
- Locations (3)
Cardiovascular Center at Universidade de Lisboa
🇵🇹Lisbon, Lisboa, Portugal
Centro Hospitalar Universitário Lisboa Norte
🇵🇹Lisbon, Lisboa, Portugal
Centro Hospitalar de São João
🇵🇹Oporto, Portugal