COVID-19
Conditions
Keywords
COVID-19, vitamin D, acute respiratory syndrome
Brief summary
Coronavirus disease 2019 (COVID-19) was declared an emergency public health problem by the World Health Organization (WHO) in March 2020. Since then, several initiatives by the medical and scientific community have sought alternatives to treat infected individuals, as well as identifying risk or protective factors for the contamination and prognosis of patients. In this perspective, vitamin D supplementation can improve some important outcomes in critically ill patients, being considered a potent immunomodulatory agent. Vitamin D deficiency is a common outcome in critically ill patients, thus making it a modifiable risk factor with great potential for reducing hospital stay and intensive care and mortality. The investigators speculate that vitamin D supplementation could have therapeutic effects in patients with COVID-19.
Interventions
DIETARY_SUPPLEMENTVitamin D
200,000 IU on admission
DIETARY_SUPPLEMENTPlacebo
200,000 IU on admission
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of flu syndrome with hospitalization criteria; * Respiratory rate ≥ 24irpm and / or saturation \<93% in room air, or belonging to the risk group for complications: 1. Chronic diseases: heart disease, diabetes mellitus, systemic arterial hypertension and neoplasms, 2. Immunosuppression, 3. Pulmonary tuberculosis; 4. Obesity; * Tomographic findings compatible with coronavirus disease.
Exclusion criteria
* Patient admitted already under invasive mechanical ventilation; * Patient admitted with severe acute respiratory syndrome and diagnosed with an etiologic agent other than SARS-CoV-2; * Prior vitamin D supplementation (above 1000 IU/day); * Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl; * Admitted patients with expected hospital discharge in less than 24 hours; * Patient unable to sign the consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospitalization | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month | total number of days that patient remained hospitalized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of cases admitted to Intensive Care Unit (ICU) | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month | total number of days that patient remained in ICU |
| Length of use of mechanic ventilator | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month | total number of days that patient remained in mechanic ventilator |
| Number and severity of symptoms | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month | — |
| Inflammatory markers | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) | C-reactive protein, IL-1alpha (pg/ml), IL-1beta (pg/ml), IL-6 (pg/ml), TNF-alpha (pg/ml), IL-1ra (pg/ml), IL-10 (pg/ml) concentration in the serum |
| Mortality | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month | number of patients that died |
| Vitamin D | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) | serum concentration |
| Creatinine | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) | serum concentration |
| Calcium | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) | serum concentration |
| Physical activity | Baseline | Baecke questionnaire (higher scores mean a higher physical activity level) |
| C-reactive protein | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) | serum concentration |
Countries
Brazil
Outcome results
None listed