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.
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
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.
- Conditions
- COVID-19 Respiratory Infection
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vitamin D |
| Low dose: | Active comparator | Vitamin 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.
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
Positive PCR test
nasopharyngeal and oropharyngeal smear
Measured: [Baseline and 12 - 14 weeks
Secondary outcomes (3)
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
COVID-19 clinical features
Fever, cough, myalgia, loss of smell or taste, abdominal pain, rhinorrhea and etc.
Measured: Baseline and 12 - 14 week
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.
- First posted8 Sep 2021
- Study start30 Oct 2020
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation in Reducing COVID-19 Morbidity Among Healthcare Workers
- ClinicalTrials.gov ID
- NCT05037253
- Acronym / sponsor ID
- 0811-20-01C
- Conditions
- COVID-19 Respiratory Infection
- Keywords
- level of 25-hydroxyvitamin D, COVID-19 disease, Healthcare Workers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
[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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assigment
| Arm | Type | Receives |
|---|---|---|
| high dose | Active comparator | Drug: Vitamin DVitamin 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. |
| Low dose: | Active comparator | Drug: Vitamin DVitamin D therapy will prescribe for 3 months at a dosage of 2,000 IU/day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- pregnancy or nursing
- a history of granulomatous diseases
- severe gastrointestinal diseases (clinically apparent malabsorption syndrome)
- liver disease
- kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DPatients 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. | Drug | Low dose:, high dose |
Primary outcome
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).
Positive PCR test
Time frame: [Baseline and 12 - 14 weeks
nasopharyngeal and oropharyngeal smear
3 secondary outcomes
Serum 25(OH)D level
Time frame: Baseline and 12 - 14 week
COVID-19 clinical features
Time frame: Baseline and 12 - 14 week
CT data
Time frame: Baseline and 12 - 14 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.