Severity of COVID-19 and Vitamin D Supplementation
Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Purpose of the study: to analyze the interlinks between serum 25(OH)D level and severity of
new coronavirus infection (COVID-19) in hospitalized patients, as well as the effect of
adding colecaciferol to standard therapy for patients in the acute period of the disease.
The study will involve at least 300 hospitalized patients with confirmed COVID-19. All study
participants will be twice assessed for serum 25 (OH) D levels: baseline and 8-10 days of
hospitalization. Following a baseline examination, patients will be randomized into 2 groups.
Group I (No. 1), vitamin D therapy begins with a dosage of 50,000 IU in the first and second
weeks. Group II (No. 2), vitamin D therapy is prescribed at a dosage of 2000 IU / day. On
8-10 days of vitamin D supplementation, all participants will be retested for serum 25 (OH) D
levels to assess the effectiveness of therapy. On 14-21 days we assessed severity of the
course, ICU hospitalization, duration of hospitalization, outcome of the disease, duration of
glucocorticoid therapy, the need for specific therapy (inhibitors IL-6), changes in
cytokine/chemokine, APPs concentration.
Phase:
Phase 4
Details
Lead Sponsor:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health