Severity of COVID-19 and Vitamin D Supplementation

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Treatments: Vitamin D

Criteria

Inclusion Criteria:

• males and females aged 18 to 75 years

• who did not take Vitamin D supplementation

• COVID-19 clinical features

• signed informed consent to participate in the research.

Exclusion Criteria:

• pregnancy or nursing

• primary hyperparathyroidism or hypercalcemia other etiologies (including 24-hydroxylase mutation)

• a history of granulomatous diseases

• severe gastrointestinal diseases (clinically apparent malabsorption syndrome)

• liver disease

• kidney disease

• individual intolerance drug

• vitamin D supplementation in a dose of more than 800 IU per

• drugs known to affect vitamin D metabolism (e.g., anticonvulsants, glucocorticoids, diuretics)

• alcohol and drug addiction.

• history of cancer (less than 5 years)