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

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: NCT04394390
Recruitment Status : 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

Tracking Information
First Submitted Date May 18, 2020
First Posted Date May 19, 2020
Last Update Posted Date May 19, 2020
Actual Study Start Date May 1, 2020
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2020)
laboratory measured vitamin D levels [ Time Frame: 45 day ]
serum 25-hydroxy-vitamin D levels
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Do Vitamin D Levels Really Correlated With Disease Severity in COVID-19 Patients?
Official Title Do Vitamin D Levels Really Correlated With Disease Severity in COVID-19 Patients?
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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 2 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 100 confirmed COVİD-19 patients (PCR)
Condition COVID
Intervention Dietary Supplement: vitamin d
vitamin D levels
Other Name: vitamin D levels
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 18, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04394390
Other Study ID Numbers 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Taner Dandinoğlu, Bursa City Hospital
Study Sponsor Bursa City Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Bursa City Hospital
Verification Date May 2020