The Efficacy of Vitamin D Supplementation in Patients With Severe and Extremely Severe COVID-19
- Conditions
- SARS-CoV2 Infection
- Interventions
- Dietary Supplement: Vitamin D (cholecalciferol)Dietary Supplement: Herbal oil
- Registration Number
- NCT05092698
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- all patients with COVID-19 admitted to the ICU with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤ 30 ng/ml]
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vit_D_suppl Vitamin D (cholecalciferol) Patients will receive 60,000 IU of cholecalciferol dissolved in 45 ml herbal oil orally or via feeding tube weekly followed by 5,000 IU of cholecalciferol (two drops) daily until discharge or death. Vit_D_placebo Herbal oil Patients will receive 45 ml of herbal oil orally or via feeding tube followed by 45 ml of herbal oil weekly followed by two drops of herbal oil daily until discharge or death.
- Primary Outcome Measures
Name Time Method Сomplete blood count dynamics 2 Change from baseline on day 15 during ICU treatment Сomplete blood count
Сomplete blood count dynamics 3 Change from baseline on day 21 during ICU treatment Сomplete blood count
C-reactive protein 2 Change from baseline on day 15 during ICU treatment Concentration of C-reactive protein
Von Willebrand factor antigen Change from baseline on day 7 during ICU treatment Concentration of Von Willebrand factor antigen
Thrombotic complications 60 days Arterial or venous thrombotic complications
Сomplete blood count Change from baseline on day 5 during ICU treatment Сomplete blood count
Сomplete blood count dynamics 1 Change from baseline on day 10 during ICU treatment Сomplete blood count
C-reactive protein Change from baseline on day 5 during ICU treatment Concentration of C-reactive protein
Proinflammatory marker 1 on day 10 during ICU treatment Concentration of D-dimer
inflammatory marker 1 Change from baseline on day 10 during ICU treatment Concentration of Interleukin-6
inflammatory marker 2 Change from baseline on day 15 during ICU treatment Concentration of Interleukin-6
Infection marker 1 Change from baseline on day 10 during ICU treatment Concentration of Procalcitonin
C-reactive protein 1 Change from baseline on day 10 during ICU treatment Concentration of C-reactive protein
C-reactive protein 3 Change from baseline on day 21 during ICU treatment Concentration of C-reactive protein
Immunogram Change from baseline on day 7 during ICU treatment The amount of NKT cells (CD3+CD56+CD16+), NK cells (CD3-CD56+CD16+)
inflammatory marker Change from baseline on day 5 during ICU treatment Concentration of Interleukin-6
Proinflammatory marker Change from baseline on day 5 during ICU treatment Concentration of D-dimer
Proinflammatory marker 2 on day 15 during ICU treatment Concentration of D-dimer
Proinflammatory marker 3 on day 21 during ICU treatment Concentration of D-dimer
inflammatory marker 3 Change from baseline on day 21 during ICU treatment Concentration of Interleukin-6
Infection marker Change from baseline on day 5 during ICU treatment Concentration of Procalcitonin
- Secondary Outcome Measures
Name Time Method Mortality 60 days The dead and survived patients ratio
Length of stay in the ICU 60 days The amount of day of ICU treatment
Infection complications 60 day The amount of Infection complications
Length of stay in the hospital 60 days The amount of day of hospital treatment
Mechanical ventilation duration 30 days The amount of mechanical ventilation days
Non-invasive Mechanical ventilation duration 30 days The amount of Non-invasive mechanical ventilation days
Trial Locations
- Locations (1)
Federal Research Clinical Center of Federal Medical & Biological Agency
🇷🇺Moscow, Russian Federation