Effect of Vitamin D on Morbidity and Mortality of the COVID-19

Study Overview
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Brief Summary
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Patients diagnosed of COVID-19 disease are randomized to receive a single dose of 100.000 IU of Cholecalciferol (Vitamin D arm) or no vitamin D (on top of the current medication used to treat COVID 19). Clinical, radiological and biochemical outcomes of COVID 19 disease as well as mortality are evaluated.

Detailed Description
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Efficacy parameters to compare both groups (vitamin D and No vitamin D). Time to reach undetectable levels of SARS COV2 Infection. Time of normalization of symptoms and clinical parameters. Time of normalization of radiological images. Time of normalization of biochemical markers. Time of normalization of molecular inflammatory markers. Transfer to the Intensive care Unit. Mortality rate.

Official Title
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Estudio Destinado a Valorar la Utilidad de Vitamina D Sobre Morbilidad y Mortalidad de la infección Por Virus SARS-COV-2 (COVID-19) en el Hospital Universitario Central de Asturias

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 year Diagnosis of COVID-19 Accept to participate in the study ( consent) Exclusion Criteria: Pregnancy Allergy to vitamin D Consumption of any form of vitamin D during the last 3 months Expected fatal outcome in the next 24 hours Cognitive deterioration
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
Interventional Model Description: Patients receiving any form. of vitamin D excluded from the study. Randomized study (Initial serum calcidiol levels blinded )
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Receiving 1 dose of 100.000 iu of Cholecalciferol when the COVID 19 Disease is diagnosed | Drug: Cholecalciferol<br>* Single doe of 100.000 IU<br>* Other names: Vitamin D;|
| No Intervention: Control<br>No vitamin D | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Percentage of patients dying during hospitalization | Time to death or hospital discharge in days (average 12 days) | 
| Admission to Intensive Care Unit (ICU) | Percentage of patients admitted to ICU and time in ICU | Time from hospital admission to discharge in days (average 12 days) | 
| Time of hospitalization | Number of days from hospital admission to discharge | Time of hospitalization in days (average 12 days) | 
| Clinical changes | Percentage of patients with symptoms after treatment (Cough, fever, headache, weakness, dyspnoea, anosmia, diarrhoea, ageusia, others ...) | At the time of hospital admission and discharge (average 12 days) | 
| Radiological changes | Changes in the percentage of patients with radiological findings of pneumonia and severity | At the time of hospital admission and discharge (average 12 days) | 
| Calcidiol changes | Calcidiol levels in ng/mL. | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| Inflammation markers changes (CRP) | C-reactive protein (CRP) in mg/L | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| Inflammation markers changes (IL-6) | Interleukin-6 (IL-6) in pg/mL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| Inflammation markers changes (Leucocytes) | Leucocytes in cells per liter | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| Inflammation markers changes (D-dimer) | D-dimer in µg/mL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| General biochemical parameters changes (Creatinine) | Creatinine in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| General biochemical parameters changes (Ferritin) | Ferritin in µg/L | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| General biochemical parameters changes (Bilirubin) | Bilirubin in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| General biochemical parameters changes (Albumin) | Albumin in g/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| General biochemical parameters changes (Haemoglobin) | Haemoglobin in g/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| General biochemical parameters changes (HDL cholesterol) | High density lipoprotein (HDL cholesterol) in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| General biochemical parameters changes (Procalcitonin) | Procalcitonin in ng/mL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| General biochemical parameters changes (Protonin) | Protonin in ng/L | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| General biochemical parameters changes (Calcium) | Calcium in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| General biochemical parameters changes (Phosphate) | Phosphate in mg/dL | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) | 
| General biochemical parameters changes (pO2) | pO2 in mmHg | At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) |