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Do Vitamin D Levels Really Correlated With Disease Severity in COVID-19 Patients? (COVIDVIT)

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ClinicalTrials.gov Identifier: NCT04394390
Recruitment Status : Unknown
Verified May 2020 by Taner Dandinoğlu, Bursa City Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Taner Dandinoğlu, Bursa City Hospital

Study Description
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Brief Summary:
Blood vitamin D levels may be associated with COVID-19 disease severity, we aimed to find out whether blood 25-hydroxy vitamin D (25(OH)D) levels were correlated with COVID-19 disease severity or noy.

Condition or disease Intervention/treatment
COVID Dietary Supplement: vitamin d

Detailed Description:

Purpose:

Vitamin D a steroid hormone has profound effects on human immunity. Active vitamin D, 1,25(OH)2D acts as an immune system modulator, preventing excessive expression of inflammatory cytokines and increasing the 'oxidative burst' potential of macrophages. Epidemiological data has linked vitamin D deficiency to increased susceptibility to acute viral respiratory infections. There is evidence that some patients with severe COVID-19 experience a cytokine storm with production of large quantities of interleukins, specifically IL-1 and IL-6. Moreover it was hipotiesied that the sufficient vitamin D levels may help to decrease IL-6 levels like tocizulamab which is a potent blocking agent of the IL-6 receptor. In present trial we aimed to find out is there a relation between the disease and vitamin D levels in COVİD-19 patients.

Material and Methods:

To find out vitamin D levels and it's relation with the disease severity serum 25-hydroxy-vitamin D levels will be measured in nearly 100 confirmed COVİD-19 patients. Same patients will also be evaluated for vital signs, laboratory and pulmoner CT findings. Demographic and medical data will also be collected. Statically significant positive or negative results and the comparison of these findings will be presented.

We think that revealing the vitamin- D levels and it's possible relation with disease severity may inspire new perspectives for future trials and treatments that spesifically focused on the novel corona virus disease.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Do Vitamin D Levels Really Correlated With Disease Severity in COVID-19 Patients?
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Dietary Supplement: vitamin d
    vitamin D levels
    Other Name: vitamin D levels

Outcome Measures
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Primary Outcome Measures :
  1. laboratory measured vitamin D levels [ Time Frame: 45 day ]
    serum 25-hydroxy-vitamin D levels


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 confirmed COVİD-19 patients (PCR)
Criteria

To find out vitamin D levels and it's relation with the disease severity serum 25-hydroxy-vitamin D levels will be measured in nearly 100 confirmed COVİD-19 patients.

İntensive care unit patients will be exluded

Contacts and Locations
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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): NCT04394390


Locations
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Turkey
Bursa City Hospital
Bursa, Dogankoy, Turkey
Sponsors and Collaborators
Bursa City Hospital
More Information
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Publications:

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Responsible Party: Taner Dandinoğlu, Taner Dandinoglu MD., Bursa City Hospital
ClinicalTrials.gov Identifier: NCT04394390    
Other Study ID Numbers: 1
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
 Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents