COVID-19 Respiratory InfectionPhase 4NCT05166005
Severity of COVID-19 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
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2020to 1 Dec 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Russia1 site
Almazov National 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 Standard Therapy on Reducing Severity of COVID-19 Among Hospitalized Patients
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.
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.
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- vitamin D
- Keywords
- level of 25-hydroxyvitamin, 25(OH)D, vitamin D, COVID-19, treatment, prevention
- Medical subject headings
- COVID-19
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 or low dose vitamin D (2,000 IU daily).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: vitamin D |
| Low dose | Placebo comparator | Vitamin D therapy will prescribe 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.
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
Measured: baseline and on 14-21 days
Secondary outcomes (4)
Serum 25(OH)D level
Measured: baseline and on 9-10 days
Serum APPs (acute phase proteins) levels, cytokine/chemokine concentrations
Change in the serum concentration of CRP (C-reactive protein), ferritin, LDH (lactate dehydrogenase), IL-6
Measured: baseline and on 14-21 days
Duration of hospitalization
number of days spent in hospital
Measured: baseline and on 14-21 days
Interleukin-6 inhibitors application
The need to use Interleukin-6 Inhibitors - olokizumab, tocilixamab, levilimab
Measured: baseline and on 14-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Apr 2020
- Primary completion23 Aug 2021
- Study completion1 Dec 2022 (estimated)
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 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
- NCT05166005
- Sponsor's protocol ID
- VitaD-COVID
- Status last verified
- Dec 2021
- First submitted
- 12 Dec 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation in Standard Therapy on Reducing Severity of COVID-19 Among Hospitalized Patients
- ClinicalTrials.gov ID
- NCT05166005
- Acronym / sponsor ID
- VitaD-COVID
- Conditions
- COVID-19 Respiratory Infection
- Keywords
- level of 25-hydroxyvitamin, 25(OH)D, vitamin D, COVID-19, treatment, prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 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
- 1 Apr 2020 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 21 Dec 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose | Active comparator | Drug: vitamin DHigh dose Vitamin D therapy will initiate at a dosage of 50,000 IU on the first and second week of hospitalization |
| Low dose | Placebo comparator | Drug: vitamin DVitamin D therapy will prescribe at a dosage of 2,000 IU/day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
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 or low dose vitamin D (2,000 IU daily). | Drug | High dose, Low dose |
Primary outcome
Combined: severity, ICU hospitalization, outcome of the disease on 14-21 days
Time frame: baseline and 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
4 secondary outcomes
Serum 25(OH)D level
Time frame: baseline and on 9-10 days
Serum APPs (acute phase proteins) levels, cytokine/chemokine concentrations
Time frame: baseline and on 14-21 days
Duration of hospitalization
Time frame: baseline and on 14-21 days
Interleukin-6 inhibitors application
Time frame: baseline and on 14-21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
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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 11 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: status not confirmed, as of the sponsor's last update on 21 Dec 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Combined: severity, ICU hospitalization, outcome of the disease on 14-21 days (time frame: baseline and on 14-21 days). 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 21 Dec 2021.