The Relationship Between Vitamin D Levels, Inflammatory Parameters and Disease Severity of COVID-19 Infection

Completed

• Conditions: Vitamin D Deficiency; Covid19
• Interventions: Diagnostic Test: Inflammatory Parameters; Other: 25 OH Vitamin D Level

• Registration Number: NCT04945577
• Lead Sponsor: Fatih Sultan Mehmet Training and Research Hospital

Brief Summary

Vitamin D deficiency increases the susceptibility to respiratory virus infections and the severity of infections. Inflammation plays a key role in pathogenesis in COVID19 while identifying clinical course and prognosis COVID19.The aim of this study was to determine the relationship between 25OH vitamin D levels, inflammatory laboratory parameters of neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), C-reactive protein (CRP) levels and disease severity of COVID19 infection.

Detailed Description

In this retrospective study 300 patients diagnosed with COVID19 were included. According to clinical classification of cases with COVID19 the patients were divided into three groups; mild (Group1), moderate (Group2) and severe/critical (Group3). The 25OH vitamin D values below 20 ng/ml were defined as deficiency, 21-29 ng/ml were defined as insufficiency, and 30 ng/ml and above were defined as normal. Patients' age, gender, comorbid diseases and laboratory values were recorded

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-06-28
• Last Update Submitted: 2021-06-28
• Study First Posted: 2021-06-30
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• The study included 300 polymerase chain reaction (PCR) test positive patients and whose 25-OH vitamin D levels were measured in the last 6 months

Exclusion Criteria

• Patients with COVID-19 whose 25-OH vitamin D levels were not measured in the last 6 months before the COVID-19 diagnosis were excluded from the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: Moderate Clinical Group	Inflammatory Parameters	patients with fever, other respiratory symptoms, and pneumonia findings based on radiological imaging
Experimental: severe/critical clinical group	Inflammatory Parameters	severe one of these as follows; patients with hypoxia (≤93% oxygen saturation), respiratory distress (RR \>30 times per minute), partial pressure of arterial blood oxygen (PaO 2 )/the fraction of inspired oxygen (FiO 2 ) ≤ 300 mmHg, patients whose chest imaging shows that lung damage develops significantly within 24 to 48 hours, or critical one of these as follows; respiratory failure requiring mechanical ventilation, signs of septic shock with multiple organ failure requiring intensive care unit admission.
Experimental: severe/critical clinical group	25 OH Vitamin D Level	severe one of these as follows; patients with hypoxia (≤93% oxygen saturation), respiratory distress (RR \>30 times per minute), partial pressure of arterial blood oxygen (PaO 2 )/the fraction of inspired oxygen (FiO 2 ) ≤ 300 mmHg, patients whose chest imaging shows that lung damage develops significantly within 24 to 48 hours, or critical one of these as follows; respiratory failure requiring mechanical ventilation, signs of septic shock with multiple organ failure requiring intensive care unit admission.
Experimental: Mild Clinical Group	Inflammatory Parameters	patients showing mild clinical symptoms without pneumonia.
Experimental: Moderate Clinical Group	25 OH Vitamin D Level	patients with fever, other respiratory symptoms, and pneumonia findings based on radiological imaging
Experimental: Mild Clinical Group	25 OH Vitamin D Level	patients showing mild clinical symptoms without pneumonia.

Primary Outcome Measures

Name	Time	Method
neutrophil count	1 day	laboratory measurement in unit of x103/uL
hemoglobin count	1 day	laboratory measurement in unit of g/dl
25-OH vitamin D	1 day	laboratory measurement in unit of ng/ml
lymphocyte count	1 day	x103/uL
neutrophil to lymphocyte ratio	1 day	laboratory measurement in unit of %
White blood cell count	1 day	laboratory measurement in unit of x103/uL
platelet count	1 day	laboratory measurement in unit of x103/uL
C-reactive protein levels	1 day	laboratory measurement in unit of mg/dL
neutrophil ratio	1 day	laboratory measurement in unit of %
lymphocyte ratio	1 day	laboratory measurement in unit of %
platelet to lymphocyte ratio	1 day	laboratory measurement in unit of %

Trial Locations

Locations (1)

Gulcan Ozturk; 🇹🇷 Istanbul, Turkey