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

NCT04945577 | Completed

• 1 other identifier: Gulcanozturk
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Covid19

Keywords

COVID-19; Vitamin D; Disease severity; Inflammatory markers

Outcome Measures

Primary Outcomes (11)

• 25-OH vitamin D

  laboratory measurement in unit of ng/ml

  1 day

• White blood cell count

  laboratory measurement in unit of x103/uL

  1 day

• neutrophil count

  laboratory measurement in unit of x103/uL

  1 day

• neutrophil ratio

  laboratory measurement in unit of %

  1 day

• lymphocyte count

  x103/uL

  1 day

• lymphocyte ratio

  laboratory measurement in unit of %

  1 day

• platelet count

  laboratory measurement in unit of x103/uL

  1 day

• hemoglobin count

  laboratory measurement in unit of g/dl

  1 day

• C-reactive protein levels

  laboratory measurement in unit of mg/dL

  1 day

• neutrophil to lymphocyte ratio

  laboratory measurement in unit of %

  1 day

• platelet to lymphocyte ratio

  laboratory measurement in unit of %

  1 day

Study Arms (3)

Experimental: Mild Clinical Group

patients showing mild clinical symptoms without pneumonia.

Diagnostic Test: Inflammatory Parameters; Other: 25 OH Vitamin D Level

Experimental: Moderate Clinical Group

patients with fever, other respiratory symptoms, and pneumonia findings based on radiological imaging

Diagnostic Test: Inflammatory Parameters; Other: 25 OH Vitamin D Level

Experimental: severe/critical clinical group

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.

Diagnostic Test: Inflammatory Parameters; Other: 25 OH Vitamin D Level

Interventions

Inflammatory Parameters DIAGNOSTIC_TEST

Laboratory measurement of patient's inflammatory status in unit of % and mg/dl

Experimental: Mild Clinical Group; Experimental: Moderate Clinical Group; Experimental: severe/critical clinical group

25 OH Vitamin D Level OTHER

Laboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl

Experimental: Mild Clinical Group; Experimental: Moderate Clinical Group; Experimental: severe/critical clinical group

Eligibility Criteria

• Age: 16 Years - 97 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID19 infection positive patients whose polymerase chain reaction (PCR) test positive patients and whose 25-OH vitamin D levels were measured in the last 6 months

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Gulcan Ozturk

Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (3)

• Ali N. Elevated level of C-reactive protein may be an early marker to predict risk for severity of COVID-19. J Med Virol. 2020 Nov;92(11):2409-2411. doi: 10.1002/jmv.26097. Epub 2020 Jun 9. No abstract available.

  PMID: 32516845 BACKGROUND

• Ali N. Role of vitamin D in preventing of COVID-19 infection, progression and severity. J Infect Public Health. 2020 Oct;13(10):1373-1380. doi: 10.1016/j.jiph.2020.06.021. Epub 2020 Jun 20.

  PMID: 32605780 BACKGROUND

• Khemka A, Suri A, Singh NK, Bansal SK. Role of Vitamin D Supplementation in Prevention and Treatment of COVID-19. Indian J Clin Biochem. 2020 Oct;35(4):502-503. doi: 10.1007/s12291-020-00908-3. Epub 2020 Jul 30. No abstract available.

  PMID: 32837034 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; COVID-19

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 30, 2021
• Study Start: July 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: June 30, 2021

Record last verified: 2021-06

Locations

TU (1)