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

COVID-19 Clinical Trial

— COVID-VIT-D  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04552951
• Other study ID #: 2020-019-PF-CAANJ
• Status: Recruiting
• Phase: Phase 4
• Start date: April 4, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2020
• Source: Fundación para la Investigación Biosanitaria del Principado de Asturias
• Contact: Jorge B Cannata-Andía, MD PhD
• Phone: *34 985 106137
• Email: cannata[@]hca.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2020
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Cholecalciferol
Single doe of 100.000 IU

Locations

Country	Name	City	State
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias

Sponsors (3)

Lead Sponsor	Collaborator
Fundación para la Investigación Biosanitaria del Principado de Asturias	Hospital Universitario Central de Asturias, Instituto de Investigación Sanitaria del Principado de Asturias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Percentage of patients dying during hospitalization	Time to death or hospital discharge in days (average 12 days)
Primary	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)
Primary	Time of hospitalization	Number of days from hospital admission to discharge	Time of hospitalization in days (average 12 days)
Primary	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)
Primary	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)
Primary	Calcidiol changes	Calcidiol levels in ng/mL.	At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)