COVID-19 Morbidity in Healthcare Workers and Vitamin D Supplementation

September 6, 2021 updated by: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

The Effect of Vitamin D Supplementation in Reducing COVID-19 Morbidity Among Healthcare Workers

[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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The COVID-19 pandemic that swept the world in 2019 radically changed not only the social sphere of life, subordinating everything around to its influence, but also the healthcare sector. It affected both its practical and scientific sides, globally changing the approach to medicine. Numerous studies around the globe are being conducted on the prevention and treatment of this infection. A significant amount of them study the role of vitamin D in the pathogenesis of the disease. Cholecalciferol (Vitamin D) is a fat-soluble vitamin that is involved in maintaining the serum calcium-phosphorus gradient. Vitamin D supplementation significantly reduces the risk of osteoporosis, and also affects the regulation of immune responses by modulating innate and adaptive immune responses. It has been shown to inhibit the proliferation of T cells, namely the subsequent transformation of Th1 cells to Th2 cells. This effect on cell proliferation and differentiation contributes to a significant decrease in the level of proinflammatory cytokines, thereby reducing the severity of immune-mediated damage. It was these mechanisms that formed the basis of the theory about the ability of vitamin D to prevent the severe course of coronavirus infection and even prevent it. At the moment, the effect of vitamin D on reducing COVID-19 morbidity is not fully confirmed.

Patients and Methods: Baseline characteristics will be recorded for all patients including medical history, height, weight, body mass index (BMI), antibodies to SARS-CoV-2 (IgG) and 25(OH)D. Serum 25(OH)D level, IgG to SARS-CoV-2 will be repeated at 12-14 weeks. Also, we will check information about clinical manifestation of COVID -19 and CT results in cases positive Ab. The research format is a prospective controlled single-center study. The study was carried out based on the Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health of the Russian Federation, October 30, 2020, to August 31, 2021. During the study, medical care workers who are working in an infectious hospital and who taking vitamin D in a controlled manner, having previously signed informed consent, will be observed. The study will be involved minimum 120 medical staff, including women and men. All subjects will be divided into three groups according to the criterion of having a higher, secondary, or no medical education. All participants in the study will be assessed twice for the level of 25-hydroxyvitamin D [25(OH)D], IgG to SARS-CoV-2 in their blood: before the start of therapy with cholecalciferol and after 3 months of Vitamin D administration. After the screening, the subjects will be randomized into 2 groups. In the Group 1, vitamin D therapy will be initiated at a dosage of 50,000 IU on the first and seventh week, followed by a switch to a daily intake of 5,000 IU for 12 weeks. In the Group 2, vitamin D therapy will be prescribed for 12 weeks at a dosage of 2,000 IU. After 3 months of taking vitamin D supplementation, all participants will undergo to repeat testing of the 25(OH)D level in the blood with an assessment of the effectiveness of the therapy. IgG titer and PCR results will be compared in two groups of participations taking different doses of vitamin D supplementation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Saint Petersburg, Russian Federation, 194021
        • Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health of the Russian Federation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: high dose
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
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.
Active Comparator: Low dose:
Vitamin D therapy will prescribe for 3 months at a dosage of 2,000 IU/day.
Drug: Vitamin D
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SARS-CoV-2 antibodies (IgG)
Time Frame: [Baseline and 12 - 14 weeks
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
Time Frame: [Baseline and 12 - 14 weeks
nasopharyngeal and oropharyngeal smear
[Baseline and 12 - 14 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum 25(OH)D level
Time Frame: Baseline and 12 - 14 week
Assessment the 25(OH)D level on different dose of Vitamin D supplementation and association between it's level with positive PCR and IgG levels
Baseline and 12 - 14 week
COVID-19 clinical features
Time Frame: Baseline and 12 - 14 week
Fever, cough, myalgia, loss of smell or taste, abdominal pain, rhinorrhea and etc.
Baseline and 12 - 14 week
CT data
Time Frame: Baseline and 12 - 14 week
Siemens Somatom Definition is a high-speed 128-slice CT scanner equipped with two X-ray tubes.
Baseline and 12 - 14 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0811-20-01C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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