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

COVID Clinical Trial

— COVIDVIT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04394390
• Other study ID #: 1
• Status: Enrolling by invitation
• Start date: May 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2020
• Source: Bursa City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 30, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 COVID-19 patients.

Intensive care unit patients will be exluded

Related Conditions & MeSH terms

• COVID

Intervention

Dietary Supplement:
• vitamin d
vitamin D levels

Locations

Country	Name	City	State
Turkey	Bursa City Hospital	Bursa	Dogankoy

Sponsors (1)

Lead Sponsor	Collaborator
Bursa City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 Apr 16;14(4):367-382. doi: 10.1016/j.dsx.2020.04.015. [Epub ahead of print] — View Citation

Silberstein M. Vitamin D: A simpler alternative to tocilizumab for trial in COVID-19? Med Hypotheses. 2020 Apr 23;140:109767. doi: 10.1016/j.mehy.2020.109767. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	laboratory measured vitamin D levels	serum 25-hydroxy-vitamin D levels	45 day