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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04945577
Other study ID # Gulcanozturk
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date August 1, 2020

Study information

Verified date June 2021
Source Fatih Sultan Mehmet Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date August 1, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers
Gender All
Age group 16 Years to 97 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Gulcan Ozturk Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. Review. — View Citation

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 Jul 30:1-2. doi: 10.1007/s12291-020-00908-3. [Epub ahead of print] — View Citation

Outcome

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