- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04394390
Vitamin D Levels in SARS-CoV-2: Do Current Adequacy Thresholds Reflect Clinical Risk? Insights From a Large Turkish Cohort (COVIDVIT)
Study Overview
Status
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 this observational study, possible relation between the disease and vitamin D levels were investigated 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 1100 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.
Presenting blood vitamin- D levels and it's possible assosiation with disease severity may inspire new perspectives for future trials spesifically focusing vitamin D levels.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dogankoy
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Bursa, Dogankoy, Turkey (Türkiye)
- Bursa City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
To find out vitamin D levels and it's relation with the disease severity serum 25-hydroxy-vitamin D levels, 1100 confirmed Covid-19 patients with available laboratory findings were included.
Exlucion Criterias:
Using immunsuppresan medical treatment. Using vitamin D or replacement history of vitamin D in last 3 months. Patients with malnutrition, immun deficiency, chronic infections, chronic other diseases such as rheumatoid arthritis, ankylosing spondilitis, lupus, hemplegia, paraplegia etc.
Study Plan
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: 12 months
|
serum 25-hydroxy-vitamin D levels
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jayawardena R, Sooriyaarachchi P, Chourdakis M, Jeewandara C, Ranasinghe P. Enhancing immunity in viral infections, with special emphasis on COVID-19: A review. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):367-382. doi: 10.1016/j.dsx.2020.04.015. Epub 2020 Apr 16.
- Silberstein M. Vitamin D: A simpler alternative to tocilizumab for trial in COVID-19? Med Hypotheses. 2020 Jul;140:109767. doi: 10.1016/j.mehy.2020.109767. Epub 2020 Apr 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Respiratory Tract Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Nutritional and Metabolic Diseases
- COVID-19
- Infections
- Vitamin D Deficiency
- Polycyclic Compounds
- Steroids
- Fused-Ring Compounds
- Secosteroids
- Vitamin D
Other Study ID Numbers
- 2020-PMR-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Research data will be available upon request from authors
(Taner Dandinoglu MD. e-mail: dandinoglu@gmail.com, Sinem Akselim MD e-mail: sinemakselim@gmail.com)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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