Vitamin D Supplementation in Patients With COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Vitamin D Supplementation in Patients With COVID-19: A Randomized, Double-blind, Placebo-controlled Trial

Conditions
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COVID-19

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients will receive 200,000 IU of vitamin D3 on admission + conventional care | Dietary Supplement: Vitamin D<br>* 200,000 IU on admission<br>|
| Placebo Comparator: Placebo<br>Patients will receive an equivalent amount of a placebo solution on admission + conventional care | Dietary Supplement: Placebo<br>* 200,000 IU on admission<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization | total number of days that patient remained hospitalized | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | number of patients that died | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month | 
| Number of cases admitted to Intensive Care Unit (ICU) | total number of days that patient remained in ICU | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month | 
| Length of use of mechanic ventilator | total number of days that patient remained in mechanic ventilator | From date of randomization until the date of hospital discharge or death, which is usually less than 1 month | 
| 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 | 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 | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) | 
| C-reactive protein | serum concentration | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) | 
| Vitamin D | serum concentration | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) | 
| Creatinine | serum concentration | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) | 
| Calcium | serum concentration | Baseline, 14 days after hospitalization and at the moment of hospital discharge or death (usually less than 1 month) | 
| Physical activity | Baecke questionnaire (higher scores mean a higher physical activity level) | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, vitamin D, acute respiratory syndrome