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Completed

NCT Number: NCT05092698

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

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.

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Key information

Conditions

SARS-CoV2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal Research Clinical Center of Federal Medical & Biological Agency

Moscow, 115682, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D (cholecalciferol)

Dietary Supplement

Patients will receive 60,000 IU of cholecalciferol dissolved in 45 ml herbal oil orally or via feeding tube after serum Vitamin D concentrations measurement followed by the same dose of cholecalciferol weekly and 5,000 IU of cholecalciferol (two drops) daily until discharge or death.

Herbal oil

Dietary Supplement

Patients will receive 45 ml of herbal oil orally or via feeding tube after serum Vitamin D concentrations measurement followed by the same dose of pure herbal oil weekly and two drops of herbal oil daily until discharge or death.

Other names: Placebo

Primary outcomes

  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

    Concentration of C-reactive protein

  6. C-reactive protein 1

    Time frame: Change from baseline on day 10 during ICU treatment

    Concentration of C-reactive protein

  7. C-reactive protein 2

    Time frame: Change from baseline on day 15 during ICU treatment

    Concentration of C-reactive protein

  8. C-reactive protein 3

    Time frame: Change from baseline on day 21 during ICU treatment

    Concentration of C-reactive protein

  9. Von Willebrand factor antigen

    Time frame: Change from baseline on day 7 during ICU treatment

    Concentration of 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

    Concentration of D-dimer

  13. Proinflammatory marker 1

    Time frame: on day 10 during ICU treatment

    Concentration of D-dimer

  14. Proinflammatory marker 2

    Time frame: on day 15 during ICU treatment

    Concentration of D-dimer

  15. Proinflammatory marker 3

    Time frame: on day 21 during ICU treatment

    Concentration of D-dimer

  16. inflammatory marker

    Time frame: Change from baseline on day 5 during ICU treatment

    Concentration of Interleukin-6

  17. inflammatory marker 1

    Time frame: Change from baseline on day 10 during ICU treatment

    Concentration of Interleukin-6

  18. inflammatory marker 2

    Time frame: Change from baseline on day 15 during ICU treatment

    Concentration of Interleukin-6

  19. inflammatory marker 3

    Time frame: Change from baseline on day 21 during ICU treatment

    Concentration of Interleukin-6

  20. Infection marker

    Time frame: Change from baseline on day 5 during ICU treatment

    Concentration of Procalcitonin

  21. Infection marker 1

    Time frame: Change from baseline on day 10 during ICU treatment

    Concentration of Procalcitonin

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Other Gov

Registry information

Acronym: COVID-VIT

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 25, 2021
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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