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

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: Cholecalciferol

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Recruiting
      • Hospital Universitario Central de Asturias
      • Contact: Jorge B Cannata-Andía, MD PhD; Phone Number: *34 985106137; Email: cannata@hca.es
      • Contact: Juan Pérez-Ortega; Phone Number: *34 985 109905; Email: juan.perez@finba.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias
• Collaborators: Hospital Universitario Central de Asturias; Instituto de Investigación Sanitaria del Principado de Asturias

Publications and helpful links

General Publications

• Cannata-Andía JB, Díaz-Sottolano A, Fernández P, Palomo-Antequera C, Herrero-Puente P, Mouzo R, Carrillo-López N, Panizo S, Ibañez GH, Cusumano CA, Ballarino C, Sánchez-Polo V, Pefaur-Penna J, Maderuelo-Riesco I, Calviño-Varela J, Gómez MD, Gómez-Alonso C, Cunningham J, Naves-Díaz M, Douthat W, Fernández-Martín JL; COVID-VIT-D trial collaborators. A single-oral bolus of 100,000 IU of cholecalciferol at hospital admission did not improve outcomes in the COVID-19 disease: the COVID-VIT-D-a randomised multicentre international clinical trial. BMC Med. 2022 Feb 18;20(1):83. doi: 10.1186/s12916-022-02290-8.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2020
• Primary Completion (Anticipated): September 14, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 2020-019-PF-CAANJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No