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

Phase 4

• Conditions: COVID-19
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT04552951
• Lead Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-04-04
• Study First Submitted: 2020-05-21
• Status Verified: 2020-09
• Primary Completion: 2020-09-14
• Study First Submitted QC: 2020-09-16
• Last Update Submitted: 2020-09-16
• Study First Posted: 2020-09-17
• Last Update Posted: 2020-09-17
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Cholecalciferol	Receiving 1 dose of 100.000 iu of Cholecalciferol when the COVID 19 Disease is diagnosed

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain