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

NCT04552951 | Unknown Phase 4 DMC

• 1 other identifier: 2020-019-PF-CAANJ
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (21)

• 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)

Study Arms (2)

Active

ACTIVE COMPARATOR

Receiving 1 dose of 100.000 iu of Cholecalciferol when the COVID 19 Disease is diagnosed

Drug: Cholecalciferol

Control

NO INTERVENTION

No vitamin D

Interventions

Cholecalciferol DRUG

Single doe of 100.000 IU

Also known as: Vitamin D

Active

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 year
• Diagnosis of COVID-19
• Accept to participate in the study ( consent)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación para la Investigación Biosanitaria del Principado de Asturias: lead
• Hospital Universitario Central de Asturias: collaborator
• Instituto de Investigación Sanitaria del Principado de Asturias: collaborator

Study Sites (1)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Related Publications (1)

• Cannata-Andia JB, Diaz-Sottolano A, Fernandez P, Palomo-Antequera C, Herrero-Puente P, Mouzo R, Carrillo-Lopez N, Panizo S, Ibanez GH, Cusumano CA, Ballarino C, Sanchez-Polo V, Pefaur-Penna J, Maderuelo-Riesco I, Calvino-Varela J, Gomez MD, Gomez-Alonso C, Cunningham J, Naves-Diaz M, Douthat W, Fernandez-Martin 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.

  PMID: 35177066 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Jorge B Cannata-Andía, MD PhD

CONTACT

*34 985 106137; cannata@hca.es

Juan Pérez-Ortega

CONTACT

*34 985109905; juan.perez@finba.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients receiving any form. of vitamin D excluded from the study. Randomized study (Initial serum calcidiol levels blinded )

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: September 17, 2020
• Study Start: April 4, 2020
• Primary Completion: September 14, 2020
• Study Completion: December 30, 2020
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)