Should Ranges of Vitamin D be Redefined to Prevent or Treat Viral Infections?

Active, not recruiting

• Conditions: COVID; Vitamin D Deficiency

• Registration Number: NCT04394390
• Lead Sponsor: Bursa City Hospital

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.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-19
• Primary Completion: 2021-05-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
laboratory measured vitamin D levels	12 months	serum 25-hydroxy-vitamin D levels

Trial Locations

Locations (1)

Bursa City Hospital; 🇹🇷 Bursa, Dogankoy, Turkey