NCT05166005

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

1.4 years

First QC Date

December 12, 2021

Last Update Submit

December 20, 2021

Conditions

COVID-19 Respiratory Infection

Keywords

level of 25-hydroxyvitamin25(OH)Dvitamin DCOVID-19treatmentprevention

Outcome Measures

Primary Outcomes (1)

  • Combined: severity, ICU hospitalization, outcome of the disease on 14-21 days

    * Severity of new coronavirus infection- moderate, severe, extremely severe * Hospitalization in intensive care unit * Outcome of the disease - recovery or fatal outcome

    baseline and on 14-21 days

Secondary Outcomes (4)

  • Serum 25(OH)D level

    baseline and on 9-10 days

  • Serum APPs (acute phase proteins) levels, cytokine/chemokine concentrations

    baseline and on 14-21 days

  • Duration of hospitalization

    baseline and on 14-21 days

  • Interleukin-6 inhibitors application

    baseline and on 14-21 days

Study Arms (2)

High dose

ACTIVE COMPARATOR

High dose Vitamin D therapy will initiate at a dosage of 50,000 IU on the first and second week of hospitalization

Drug: vitamin D

Low dose

PLACEBO COMPARATOR

Vitamin D therapy will prescribe at a dosage of 2,000 IU/day

Drug: vitamin D

Interventions

vitamin DDRUG

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).

High doseLow dose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Almazov National Medical Research Centre, of the Ministry of Health of the Russian Federation

Saint Petersburg, 194021, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2021

First Posted

December 21, 2021

Study Start

April 1, 2020

Primary Completion

August 23, 2021

Study Completion

December 1, 2022

Last Updated

December 21, 2021

Record last verified: 2021-12

Locations

RU(1)