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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04552951
Recruitment Status : Unknown
Verified September 2020 by Fundación para la Investigación Biosanitaria del Principado de Asturias.
Recruitment status was:  Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborators:
Hospital Universitario Central de Asturias
Instituto de Investigación Sanitaria del Principado de Asturias
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Cholecalciferol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients receiving any form. of vitamin D excluded from the study. Randomized study (Initial serum calcidiol levels blinded )
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 4, 2020
Estimated Primary Completion Date : September 14, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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 Name: Vitamin D

No Intervention: Control
No vitamin D



Primary Outcome Measures :
  1. Mortality [ Time Frame: Time to death or hospital discharge in days (average 12 days) ]
    Percentage of patients dying during hospitalization

  2. Admission to Intensive Care Unit (ICU) [ Time Frame: Time from hospital admission to discharge in days (average 12 days) ]
    Percentage of patients admitted to ICU and time in ICU

  3. Time of hospitalization [ Time Frame: Time of hospitalization in days (average 12 days) ]
    Number of days from hospital admission to discharge

  4. Clinical changes [ Time Frame: 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 ...)

  5. Radiological changes [ Time Frame: At the time of hospital admission and discharge (average 12 days) ]
    Changes in the percentage of patients with radiological findings of pneumonia and severity

  6. Calcidiol changes [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Calcidiol levels in ng/mL.

  7. Inflammation markers changes (CRP) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    C-reactive protein (CRP) in mg/L

  8. Inflammation markers changes (IL-6) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Interleukin-6 (IL-6) in pg/mL

  9. Inflammation markers changes (Leucocytes) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Leucocytes in cells per liter

  10. Inflammation markers changes (D-dimer) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    D-dimer in µg/mL

  11. General biochemical parameters changes (Creatinine) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Creatinine in mg/dL

  12. General biochemical parameters changes (Ferritin) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Ferritin in µg/L

  13. General biochemical parameters changes (Bilirubin) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Bilirubin in mg/dL

  14. General biochemical parameters changes (Albumin) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Albumin in g/dL

  15. General biochemical parameters changes (Haemoglobin) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Haemoglobin in g/dL

  16. General biochemical parameters changes (HDL cholesterol) [ Time Frame: 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

  17. General biochemical parameters changes (Procalcitonin) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Procalcitonin in ng/mL

  18. General biochemical parameters changes (Protonin) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Protonin in ng/L

  19. General biochemical parameters changes (Calcium) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Calcium in mg/dL

  20. General biochemical parameters changes (Phosphate) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    Phosphate in mg/dL

  21. General biochemical parameters changes (pO2) [ Time Frame: At the time of hospital admission (before initiation of treatment) and at hospital discharge (average 12 days) ]
    pO2 in mmHg



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552951


Contacts
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Contact: Jorge B Cannata-Andía, MD PhD *34 985 106137 cannata@hca.es
Contact: Juan Pérez-Ortega *34 985109905 juan.perez@finba.es

Locations
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Spain
Hospital Universitario Central de Asturias Recruiting
Oviedo, Asturias, Spain, 33011
Contact: Jorge B Cannata-Andía, MD PhD    *34 985106137    cannata@hca.es   
Contact: Juan Pérez-Ortega    *34 985 109905    juan.perez@finba.es   
Sponsors and Collaborators
Fundación para la Investigación Biosanitaria del Principado de Asturias
Hospital Universitario Central de Asturias
Instituto de Investigación Sanitaria del Principado de Asturias
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundación para la Investigación Biosanitaria del Principado de Asturias
ClinicalTrials.gov Identifier: NCT04552951    
Other Study ID Numbers: 2020-019-PF-CAANJ
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents