The Efficacy of Vitamin D Supplementation in Patients With Severe and Extremely Severe COVID-19
Condition: SARS-CoV2 Infection
MeSH terms: COVID-19
Study type: Interventional

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.
    

Intervention name(s): Vitamin D (cholecalciferol); Herbal oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; 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 intervention name(s): Placebo
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: severe acute respiratory syndrome coronavirus 2 (SARS-CoV2); coronavirus disease 2019 (COVID-19); severe and extremely severe disease; Vitamin D; cholecalciferol