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COVID-19 Respiratory InfectionPhase 4NCT05037253

COVID-19 Morbidity in Healthcare Workers and Vitamin D Supplementation

A Phase 4 study testing Vitamin D in people with COVID-19 Respiratory Infection, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
COVID-19 Respiratory Infection
What is being tested?
Vitamin D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteRussia
Study dates
30 Oct 2020to 30 May 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Russia1 site
  • 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

Other trials in Russia

About this study

Official title: 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.

Read the 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.

Being tested
Vitamin D
Keywords
level of 25-hydroxyvitamin D, COVID-19 disease, Healthcare Workers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05037253
Study groupRoleWhat they receive
high doseActive comparatorVitamin 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.
Receives: Drug: Vitamin D
Low dose:Active comparatorVitamin D therapy will prescribe for 3 months at a dosage of 2,000 IU/day.
Receives: Drug: Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: [Baseline and 12 - 14 weeks

  2. Positive PCR test

    nasopharyngeal and oropharyngeal smear

    Measured: [Baseline and 12 - 14 weeks

Secondary outcomes (3)
  1. Serum 25(OH)D level

    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

    Measured: Baseline and 12 - 14 week

  2. COVID-19 clinical features

    Fever, cough, myalgia, loss of smell or taste, abdominal pain, rhinorrhea and etc.

    Measured: Baseline and 12 - 14 week

  3. CT data

    Siemens Somatom Definition is a high-speed 128-slice CT scanner equipped with two X-ray tubes.

    Measured: Baseline and 12 - 14 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2021
  2. Study start30 Oct 2020
  3. Primary completion30 May 2021
  4. Study completion30 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assigment
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05037253
Sponsor's protocol ID
0811-20-01C
Status last verified
Aug 2021
First submitted
25 Aug 2021
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin D in people with COVID-19 Respiratory Infection, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARS-CoV-2 antibodies (IgG) (time frame: [Baseline and 12 - 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.

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