Covid19 Clinical Trial
Official title:
The Relationship Between Vitamin D Levels, Inflammatory Parameters and Disease Severity of COVID-19 Infection: A Retrospective Study
| 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 |
| Verified date | June 2021 |
| Source | Fatih Sultan Mehmet Training and Research Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Gulcan Ozturk | Istanbul |
| Lead Sponsor | Collaborator |
|---|---|
| Fatih Sultan Mehmet Training and Research Hospital |
Turkey,
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
| 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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