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The Efficacy of Vitamin D Supplementation in Patients With Severe and Extremely Severe COVID-19 (COVID-VIT)

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ClinicalTrials.gov Identifier: NCT05092698
Recruitment Status : Recruiting
First Posted : October 25, 2021
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Brief Summary:

Despite the successful treatment of patients with moderate coronavirus disease 2019 (COVID-19), outcomes for patients with severe disease remain unsatisfactory. In this category of patients, the course of the disease is complicated by the development of acute respiratory distress syndrome (ARDS) and the need for mechanical ventilation in the intensive care unit (ICU). Mortality in this category of patients reaches 85%. The lack of effective treatment for COVID-19 has prompted scientists to look for new strategies to reduce the incidence and severity of COVID-19, disease progression, and mortality.

Disease severity and mortality rates due to COVID-19 infection are greater in the elderly and chronically ill patients, populations at high risk for vitamin D deficiency. Vitamin D plays an important role in immune function and inflammation.

A number of experimental studies have shown that stimulation of vitamin D receptors can improve the course of ARDS due to inhibition of the hyperimmune inflammatory response, regulation of the renin-angiotensin system, modulation of neutrophil activity, maintenance of the integrity of the pulmonary epithelial barrier and stimulation of epithelial repair, as well as by reducing hypercoagulation.

Several studies on ICU patients have reported that low vitamin D (25(OH)D) concentrations are associated with a higher risk of negative outcomes such as death, organ failure, prolonged mechanical ventilation, a higher rate of ventilation-associated pneumonia, and sepsis.

While the available evidence to-date, from largely poor-quality observational studies, may be viewed as showing a trend for an association between low serum 25(OH)D levels and COVID-19 related health outcomes, this relationship was not found to be statistically significant. Calcifediol supplementation may have a protective effect on COVID-19 related ICU admissions.


Condition or disease Intervention/treatment Phase
SARS-CoV2 Infection Dietary Supplement: Vitamin D (cholecalciferol) Not Applicable

Detailed Description:

The aim of the study is to evaluate the efficacy of vitamin D (cholecalciferol) supplementation in patients with severe and extremely severe disease caused by the SARS-CoV-2 virus, admitted to an ICU of the COVID-center on the first day and in dynamics until discharge from the hospital or death. Patients with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤ 30 ng/ml] will be randomized to two groups: 1 - patients will receive 60,000 IU of cholecalciferol supplementation; 2 - patients will receive matched placebo.

The demographic and clinical data will be collected. Laboratory data (hemoglobin, lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, Interleukin-6, procalcitonin, ferritin, glucose level, high-sensitive troponin Т, vitamin D level (25(OH)D), acid-base balance, signs of a secondary bacterial infection, immunogram, Von Willebrand factor antigen and Instrumental data (CT-scan, Electrocardiography, echocardiography, arterial and venous ultrasound investigation) will be analysed. The frequency of complications, duration of mechanical ventilation, length of stay in the ICU and in the hospital, and mortality will be evaluated.

This study is single-centre prospective randomized placebo-controlled trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Efficacy of Vitamin D Supplementation in Patients With Severe and Extremely Severe COVID-19
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Vit_D_suppl
Patients will receive 60,000 IU of cholecalciferol dissolved in 45 ml herbal oil orally or via feeding tube followed by 60,000 IU of cholecalciferol dissolved in 45 ml herbal oil weekly until discharge or death.
Dietary Supplement: Vitamin D (cholecalciferol)
Patients will receive either 60,000 IU of cholecalciferol dissolved in 45 ml herbal oil or matched placebo orally or via feeding tube after serum Vitamin D concentrations measurement followed by either the same dose of cholecalciferol or 45 ml of pure herbal oil weekly until discharge or death.
Other Name: herbal oil

Placebo Comparator: Vit_D_placebo
Patients will receive 45 ml of herbal oil orally or via feeding tube followed by 45 ml of herbal oil weekly until discharge or death.
Dietary Supplement: Vitamin D (cholecalciferol)
Patients will receive either 60,000 IU of cholecalciferol dissolved in 45 ml herbal oil or matched placebo orally or via feeding tube after serum Vitamin D concentrations measurement followed by either the same dose of cholecalciferol or 45 ml of pure herbal oil weekly until discharge or death.
Other Name: herbal oil




Primary Outcome Measures :
  1. Сomplete blood count [ Time Frame: Change from baseline on day 5 during ICU treatment ]
    Сomplete blood count

  2. Сomplete blood count dynamics 1 [ Time Frame: Change from baseline on day 10 during ICU treatment ]
    Сomplete blood count

  3. Сomplete blood count dynamics 2 [ Time Frame: Change from baseline on day 15 during ICU treatment ]
    Сomplete blood count

  4. Сomplete blood count dynamics 3 [ Time Frame: Change from baseline on day 21 during ICU treatment ]
    Сomplete blood count

  5. C-reactive protein [ Time Frame: Change from baseline on day 5 during ICU treatment ]
    C-reactive protein

  6. C-reactive protein 1 [ Time Frame: Change from baseline on day 10 during ICU treatment ]
    C-reactive protein

  7. C-reactive protein 2 [ Time Frame: Change from baseline on day 15 during ICU treatment ]
    C-reactive protein

  8. C-reactive protein 3 [ Time Frame: Change from baseline on day 21 during ICU treatment ]
    C-reactive protein

  9. Von Willebrand factor antigen [ Time Frame: Change from baseline on day 7 during ICU treatment ]
    Von Willebrand factor antigen

  10. Thrombotic complications [ Time Frame: 60 days ]
    Arterial or venous thrombotic complications

  11. Immunogram [ Time Frame: Change from baseline on day 7 during ICU treatment ]
    The amount of NKT cells (CD3+CD56+CD16+), NK cells (CD3-CD56+CD16+)

  12. Proinflammatory marker [ Time Frame: Change from baseline on day 5 during ICU treatment ]
    D-dimer

  13. Proinflammatory marker 1 [ Time Frame: on day 10 during ICU treatment ]
    D-dimer

  14. Proinflammatory marker 2 [ Time Frame: on day 15 during ICU treatment ]
    D-dimer

  15. Proinflammatory marker 3 [ Time Frame: on day 21 during ICU treatment ]
    D-dimer

  16. inflammatory marker [ Time Frame: Change from baseline on day 5 during ICU treatment ]
    Interleukin-6

  17. inflammatory marker 1 [ Time Frame: Change from baseline on day 10 during ICU treatment ]
    Interleukin-6

  18. inflammatory marker 2 [ Time Frame: Change from baseline on day 15 during ICU treatment ]
    Interleukin-6

  19. inflammatory marker 3 [ Time Frame: Change from baseline on day 21 during ICU treatment ]
    Interleukin-6

  20. Infection marker [ Time Frame: Change from baseline on day 5 during ICU treatment ]
    Procalcitonin

  21. Infection marker 1 [ Time Frame: Change from baseline on day 10 during ICU treatment ]
    Procalcitonin


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 60 days ]
    The dead and survived patients ratio

  2. Mechanical ventilation duration [ Time Frame: 30 days ]
    The amount of mechanical ventilation days

  3. Non-invasive Mechanical ventilation duration [ Time Frame: 30 days ]
    The amount of Non-invasive mechanical ventilation days

  4. Length of stay in the ICU [ Time Frame: 60 days ]
    The amount of day of ICU treatment

  5. Length of stay in the hospital [ Time Frame: 60 days ]
    The amount of day of hospital treatment

  6. Infection complications [ Time Frame: 60 day ]
    The amount of Infection complications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients with COVID-19 admitted to the ICU with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤ 30 ng/ml]

Exclusion Criteria:

  • less than 24 hours in ICU by any reason
  • chronic decompensated disease with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure) with a life expectancy of less than 48 hours
  • atonic coma
  • allergic reaction on cholecalciferol or herbal oil

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05092698


Contacts
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Contact: Mikhail V Bychinin, PhD +7 926 217-99-72 drbychinin@gmail.com
Contact: Irina A Mandel, PhD +79039528337 irina.a.mandel@gmail.com

Locations
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Russian Federation
Federal Research Clinical Center of Federal Medical & Biological Agency Recruiting
Moscow, Russian Federation, 115682
Contact: Mikhail V Bychinin, PhD    +7 926 217-99-72    drbychinin@gmail.com   
Contact: Irina A Mandel, PhD    +79039528337    irina.a.mandel@gmail.com   
Sponsors and Collaborators
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Investigators
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Study Chair: Tatiana V Klypa, ScD Federal Research Clinical Center of Federal Medical & Biological Agency
Publications:
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Responsible Party: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
ClinicalTrials.gov Identifier: NCT05092698    
Other Study ID Numbers: COVID-VIT
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia:
severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)
coronavirus disease 2019 (COVID-19)
severe and extremely severe disease
Vitamin D
cholecalciferol
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents