Vitamin D DeficiencyNCT04945577
The Relationship Between Vitamin D Levels, Inflammatory Parameters and Disease Severity of COVID-19 Infection
An observational study of Vitamin D Deficiency and Covid19, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 16 to 97 years
- Conditions the study is for
- Vitamin D Deficiency, Covid19
- What is being tested?
- Inflammatory Parameters and 25 OH Vitamin D Level
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 97 years
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Vitamin D Levels, Inflammatory Parameters and Disease Severity of COVID-19 Infection: A Retrospective Study
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.
Read the 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
- Conditions
- Vitamin D Deficiency, Covid19
- Being tested
- Inflammatory Parameters, 25 OH Vitamin D Level
- Keywords
- COVID-19, Vitamin D, Disease severity, Inflammatory markers
- Medical subject headings
- Vitamin D Deficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammatory ParametersDiagnostic test
Laboratory measurement of patient's inflammatory status in unit of % and mg/dl
25 OH Vitamin D LevelOther
Laboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Mild Clinical Group | patients showing mild clinical symptoms without pneumonia. Receives: 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 Receives: 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. Receives: Diagnostic Test: Inflammatory Parameters; Other: 25 OH Vitamin D Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
25-OH vitamin D
laboratory measurement in unit of ng/ml
Measured: 1 day
White blood cell count
laboratory measurement in unit of x103/uL
Measured: 1 day
neutrophil count
laboratory measurement in unit of x103/uL
Measured: 1 day
neutrophil ratio
laboratory measurement in unit of %
Measured: 1 day
lymphocyte count
x103/uL
Measured: 1 day
lymphocyte ratio
laboratory measurement in unit of %
Measured: 1 day
platelet count
laboratory measurement in unit of x103/uL
Measured: 1 day
hemoglobin count
laboratory measurement in unit of g/dl
Measured: 1 day
C-reactive protein levels
laboratory measurement in unit of mg/dL
Measured: 1 day
neutrophil to lymphocyte ratio
laboratory measurement in unit of %
Measured: 1 day
platelet to lymphocyte ratio
laboratory measurement in unit of %
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Jul 2020
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945577
- Sponsor's protocol ID
- Gulcanozturk
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32516845Ali 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.
PubMed 32605780Khemka 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.
PubMed 32837034
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Vitamin D Levels, Inflammatory Parameters and Disease Severity of COVID-19 Infection: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04945577
- Acronym / sponsor ID
- Gulcanozturk
- Conditions
- Vitamin D Deficiency, Covid19
- Keywords
- COVID-19, Vitamin D, Disease severity, Inflammatory markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Mild Clinical Group | – | Diagnostic Test: Inflammatory Parameters, Other: 25 OH Vitamin D Levelpatients showing mild clinical symptoms without pneumonia. |
| Experimental: Moderate Clinical Group | – | Diagnostic Test: Inflammatory Parameters, Other: 25 OH Vitamin D Levelpatients with fever, other respiratory symptoms, and pneumonia findings based on radiological imaging |
| Experimental: severe/critical clinical group | – | Diagnostic Test: Inflammatory Parameters, Other: 25 OH Vitamin D Levelsevere 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. |
Who may qualify
- Ages
- 16 to 97 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflammatory ParametersLaboratory measurement of patient's inflammatory status in unit of % and mg/dl | Diagnostic test | Experimental: Mild Clinical Group, Experimental: Moderate Clinical Group, Experimental: severe/critical clinical group |
| 25 OH Vitamin D LevelLaboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl | Other | Experimental: Mild Clinical Group, Experimental: Moderate Clinical Group, Experimental: severe/critical clinical group |
Primary outcome
25-OH vitamin D
Time frame: 1 day
laboratory measurement in unit of ng/ml
White blood cell count
Time frame: 1 day
laboratory measurement in unit of x103/uL
neutrophil count
Time frame: 1 day
laboratory measurement in unit of x103/uL
neutrophil ratio
Time frame: 1 day
laboratory measurement in unit of %
lymphocyte count
Time frame: 1 day
x103/uL
lymphocyte ratio
Time frame: 1 day
laboratory measurement in unit of %
platelet count
Time frame: 1 day
laboratory measurement in unit of x103/uL
hemoglobin count
Time frame: 1 day
laboratory measurement in unit of g/dl
C-reactive protein levels
Time frame: 1 day
laboratory measurement in unit of mg/dL
neutrophil to lymphocyte ratio
Time frame: 1 day
laboratory measurement in unit of %
platelet to lymphocyte ratio
Time frame: 1 day
laboratory measurement in unit of %
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Background: PubMed 32516845Ali 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.
- Background: PubMed 32605780Ali 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.
- Background: PubMed 32837034Khemka 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Covid19, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25-OH vitamin D (time frame: 1 day). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04945577, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.