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

May 18, 2020 updated by: Taner Dandinoğlu, Bursa City Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Dogankoy
      • Bursa, Dogankoy, Turkey
        • Bursa City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

100 confirmed COVİD-19 patients (PCR)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
laboratory measured vitamin D levels
Time Frame: 45 day
serum 25-hydroxy-vitamin D levels
45 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Anticipated)

June 15, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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