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Severity of COVID-19 and Vitamin D Supplementation

NCT05166005 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2021-12-21

No results posted yet for this study

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.

Conditions

  • COVID-19 Respiratory Infection

Interventions

DRUG

vitamin D

Patients will be randomised to receive either high dose vitamin D (50,000 IU weekly) on the first and second week or low dose vitamin D (2,000 IU daily).

Sponsors & Collaborators

  • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2021-08-23
Completion
2022-12-01

Countries

  • Russia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05166005 on ClinicalTrials.gov