Covid-19, Respiratory Distress Syndrome, Vitamin D Deficiency
Conditions
Brief summary
Single center, open label randomized clinical trial. Study location: tertiary hospital center (University Hospital Split, Croatia). All COVID-19 patients with positive PCR test admitted to ICU and in need for respiratory support will be eligible for inclusion in this study. Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (\<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test. Intervention: All patients included in this study will receive standard of care. Patients randomized into intervention group will be receiving 10 000 IU of cholecalciferol daily. Supplement will be administered orally or via gastric tube during ICU stay or for at least 14 days in case of ICU discharge before day 14. Supplementation will begin within 48 hours of admission to ICU. Supplement will be prepared and administered by experienced nursing staff. For patients receiving supplementation, vitamin D levels will be checked on days 7 and 14. In case that vitamin D levels are \> 150 nmol/l or if the calcium levels are consistently \> 2.6 mmol/l, further supplementation will be stopped. Outcomes: Primary outcome is number of days spent on ventilator. Secondary outcomes: all-cause mortality on day 28, all-cause mortality on day 60, mortality at hospital discharge, clinical improvement at day 28 (WHO clinical progression scale), days spent in ICU, days spent in hospital after discharge from ICU, need for dialysis at day 28, bacterial superinfections, neutrophile to lymphocyte ratio, disease severity (CRP levels, PaO2/FiO2 ratio, D-dimer levels, fibrinogen, ferritin, PCT), adverse outcomes. Hypothesis: patients receiving Vitamin D supplementation will have shorter number of days spent on mechanical ventilation.
Interventions
DIETARY_SUPPLEMENTcholecalciferol
daily supplementation of cholecalciferol, 10 000 IU, during 14 days
Sponsors
University Hospital of Split
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients admitted to ICU with severe COVID-19 disease and in need for invasive or non-invasive respiratory support with low levels of vitamin D (\<50 nmol/l) measured on admission. All patients are older than 18 years and have confirmed COVID-19 disease with PCR test.
Exclusion criteria
* Patients will be excluded from study in case of calcium levels that are consistently above normal serum range (\> 2.6 mmol/L, \> 10.5 mg/dL) or if vitamin D levels are \> 150 nmol/L.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of days on mechanical ventilation | Daily, through study completion, on average 6 months | Number of days spent on mechanical ventilation for each patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality on day 60 | day 60 | Number of patients alive on day 60 |
| clinical improvement at day 28 | day 28 | World Health Organization Clinical progression scale. Values are from 0 to 10 with higher score meaning worse clinical status |
| Number of days spent in ICU | Daily, through study completion, on average 6 months | Number of days spent in Intensive care unit for each patient |
| Number of days spent in hospital after ICU discharge | Daily, through study completion, on average 6 months | Number of days spent in hospital for each patient |
| Acute renal failure | Day 28 | Number of patients with need for renal replacement therapy |
| All-cause mortality on day 28 | day 28 | Number of patients alive on day 28 |
| CRP levels (mg/ml) | Daily, through study completion, on average 6 months | blood tests will be taken daily during hospital stay |
| prokalcitonin levels (ng/ml) | Daily, through study completion, on average 6 months | blood tests will be taken daily during hospital stay |
| fibrinogen levels (g/L) | Daily, through study completion, on average 6 months | blood tests will be taken daily during hospital stay |
| D-dimer levels (mg/l) | Daily, through study completion, on average 6 months | blood tests will be taken daily during hospital stay |
| adverse outcomes | Daily, through study completion, on average 6 months | Number of patients with elevated serum calcium levels |
| bacterial superinfections | Daily, through study completion, on average 6 months | Number of patients with bacterial superinfections during hospitalization |
Countries
Croatia
Outcome results
None listed