NCT05037253

Brief Summary

\[Aim\] Purpose of the study: to analyze the effect of vitamin D supplementation in reducing COVID-19 morbidity and severity in healthcare workers. The study will involve a minimum of 120 medical staff. All participants in the study will assess twice for serum 25(OH)D level: baseline and after 3 months of Vitamin D supplementation. After the baseline examination, the subjects will be randomized into 2 groups. In the first (No. 1), vitamin D therapy will initiate at a dosage of 50,000 IU on the first and second week, followed by a switch to a daily intake of 5,000 IU for 3 months. In the second group (No. 2), vitamin D therapy will prescribe for 3 months at a dosage of 2,000 IU/day. After 3 months of vitamin D supplementation, all participants will undergo to repeat testing of serum 25(OH)D level with an assessment of the effectiveness of the therapy. Body mass index (BMI), height, weight, SARS-CoV-2 antibodies (IgG), 25-hydroxycalciferol (25(OH)D) and presence of acute viral infection futures, parameters assessed after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

October 30, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

August 25, 2021

Last Update Submit

September 6, 2021

Conditions

COVID-19 Respiratory Infection

Keywords

level of 25-hydroxyvitamin DCOVID-19 diseaseHealthcare Workers

Outcome Measures

Primary Outcomes (2)

  • SARS-CoV-2 antibodies (IgG)

    COVID-19 presence in healthcare workers in infectious clinic will be determined by detection of IgG to SARS-CoV-2 (reference values: \> 1.1 - positive test; \< 0.8 - negative test; the result of 0.8 between 1.1 - boundary test) (Enzyme immunoassay kits - Vector-Best, Novosibirsk, Russia).

    [Baseline and 12 - 14 weeks

  • Positive PCR test

    nasopharyngeal and oropharyngeal smear

    [Baseline and 12 - 14 weeks

Secondary Outcomes (3)

  • Serum 25(OH)D level

    Baseline and 12 - 14 week

  • COVID-19 clinical features

    Baseline and 12 - 14 week

  • CT data

    Baseline and 12 - 14 week

Study Arms (2)

high dose

ACTIVE COMPARATOR

Vitamin D therapy will initiate at a dosage of 50,000 IU on the first and second week, followed by a switch to a daily intake of 5,000 IU for 3 months.

Drug: Vitamin D

Low dose:

ACTIVE COMPARATOR

Vitamin D therapy will prescribe for 3 months 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, followed by a switch to a daily intake of 5,000 IU for 3 months or low dose vitamin D (2,000 IU weekly) for 3 months.

Low dose:high dose

Eligibility Criteria

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

You may qualify if:

  • males and females aged 18 to 65 years
  • who did not take Vitamin D supplementation
  • healthcare workers, during the pandemic
  • who had not previously tolerated new coronavirus infection

You may not qualify if:

  • pregnancy or nursing
  • a history of granulomatous diseases
  • severe gastrointestinal diseases (clinically apparent malabsorption syndrome)
  • liver disease
  • kidney disease
  • individual intolerance drug
  • vitamin D supplementation
  • drugs known to affect vitamin D metabolism (e.g., anticonvulsants, glucocorticoids, diuretics)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Saint Petersburg, 194021, Russia

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assigment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

September 8, 2021

Study Start

October 30, 2020

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

September 8, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)