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
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|Condition or disease||Intervention/treatment|
|COVID||Dietary Supplement: vitamin d|
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]|
|Estimated Enrollment :||100 participants|
|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|
- Dietary Supplement: vitamin d
vitamin D levelsOther Name: vitamin D levels
- laboratory measured vitamin D levels [ Time Frame: 45 day ]serum 25-hydroxy-vitamin D levels
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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|
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
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
|Bursa City Hospital|
|Bursa, Dogankoy, Turkey|
|Responsible Party:||Taner Dandinoğlu, Taner Dandinoglu MD., Bursa City Hospital|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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