Clinical trial NCT04394390: Should Ranges of Vitamin D be Redefined to Prevent or Treat Viral Infections?
Official title: Is it Too Low to Prevent us From Infections? Should Ranges of Vitamin D be Redefined to Prevent or Treat Viral Infections?
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID
Vitamin D Deficiency
Keywords: covid-19, infection, vitamin D, prevention
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-19
Enrollment: 1100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1100 confirmed COVİD-19 patients (PCR)

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.

Eligibility 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.

Primary outcomes:
measure: laboratory measured vitamin D levels
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa City Hospital
state: Dogankoy
Study officials:
References:
citation: 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.
citation: 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.