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

Fundación para la Investigación Biosanitaria del Principado de Asturias80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

COVID-19

Interventions

CholecalciferolDRUG

Single doe of 100.000 IU

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

RECRUITING

Outcomes

Primary Outcomes

Mortality

Percentage of patients dying during hospitalization

Time frame: 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 frame: Time from hospital admission to discharge in days (average 12 days)

Time of hospitalization

Number of days from hospital admission to discharge

Time frame: 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 ...)

Time frame: 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

Time frame: At the time of hospital admission and discharge (average 12 days)

Calcidiol changes

Calcidiol levels in ng/mL.

Time frame: 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

Time frame: 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

Central Contacts

Jorge B Cannata-Andía, MD PhD

CONTACT

*34 985 106137 cannata@hca.es

Juan Pérez-Ortega

CONTACT

*34 985109905 juan.perez@finba.es

Data from ClinicalTrials.gov

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Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)