MedDataX Logo

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

NCT ID: NCT04945577

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency Covid19

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

COVID-19 Vitamin D Disease severity Inflammatory markers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: Mild Clinical Group

patients showing mild clinical symptoms without pneumonia.

Inflammatory Parameters

Intervention Type DIAGNOSTIC_TEST

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

25 OH Vitamin D Level

Intervention Type OTHER

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

Inflammatory Parameters

Intervention Type DIAGNOSTIC_TEST

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

25 OH Vitamin D Level

Intervention Type OTHER

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.

Inflammatory Parameters

Intervention Type DIAGNOSTIC_TEST

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

25 OH Vitamin D Level

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inflammatory Parameters

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

Intervention Type DIAGNOSTIC_TEST

25 OH Vitamin D Level

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

97 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gulcan Ozturk

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32516845 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32605780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32837034 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Gulcanozturk

Identifier Type: -

Identifier Source: org_study_id