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

Sponsor
Fatih Sultan Mehmet Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04945577
Collaborator
(none)
300
1
1
294.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Inflammatory Parameters
  • Other: 25 OH Vitamin D Level

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 Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
The Relationship Between Vitamin D Levels, Inflammatory Parameters and Disease Severity of COVID-19 Infection: A Retrospective Study
Actual Study Start Date :
Jul 1, 2020
Actual Primary Completion Date :
Aug 1, 2020
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mild Clinical Group

patients showing mild clinical symptoms without pneumonia.

Diagnostic Test: Inflammatory Parameters
Laboratory measurement of patient's inflammatory status in unit of % and mg/dl

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

Experimental: Moderate Clinical Group

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

Diagnostic Test: Inflammatory Parameters
Laboratory measurement of patient's inflammatory status in unit of % and mg/dl

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 25-OH vitamin D [1 day]

    laboratory measurement in unit of ng/ml

  2. White blood cell count [1 day]

    laboratory measurement in unit of x103/uL

  3. neutrophil count [1 day]

    laboratory measurement in unit of x103/uL

  4. neutrophil ratio [1 day]

    laboratory measurement in unit of %

  5. lymphocyte count [1 day]

    x103/uL

  6. lymphocyte ratio [1 day]

    laboratory measurement in unit of %

  7. platelet count [1 day]

    laboratory measurement in unit of x103/uL

  8. hemoglobin count [1 day]

    laboratory measurement in unit of g/dl

  9. C-reactive protein levels [1 day]

    laboratory measurement in unit of mg/dL

  10. neutrophil to lymphocyte ratio [1 day]

    laboratory measurement in unit of %

  11. platelet to lymphocyte ratio [1 day]

    laboratory measurement in unit of %

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 97 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gulcan Ozturk Istanbul Turkey 34752

Sponsors and Collaborators

  • Fatih Sultan Mehmet Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fatih Sultan Mehmet Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04945577
Other Study ID Numbers:
  • Gulcanozturk
First Posted:
Jun 30, 2021
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatih Sultan Mehmet Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2021