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Clinical Trials/NCT04394390
NCT04394390
Completed
Not Applicable

Vitamin D Levels in SARS-CoV-2: Do Current Adequacy Thresholds Reflect Clinical Risk? Insights From a Large Turkish Cohort

Bursa City Hospital1 site in 1 country1,100 target enrollmentMay 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Bursa City Hospital
Enrollment
1100
Locations
1
Primary Endpoint
laboratory measured vitamin D levels
Status
Completed
Last Updated
2 months ago

Overview

Brief Summary

Blood vitamin D levels may be associated with severity of viral infections. To find out If there is a statistically significant relation between blood 25-hydroxy vitamin D (25(OH)D) levels and disease severity, patients with Covid-19 viral infection were investigated.

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2020
End Date
August 30, 2025
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bursa City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Taner Dandinoğlu

Taner Dandinoglu MD. Principal Investigator, Physical Medicine and Rehabilitation (PMR) specialist.

Bursa City Hospital

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

laboratory measured vitamin D levels

Time Frame: 12 months

serum 25-hydroxy-vitamin D levels

Study Sites (1)

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