COVID-19 PandemicNCT05221983
COVID-19 and Vitamin D: Length of Hospital Stay and Mortality
An observational study of COVID-19 Pandemic and Vitamin D Deficiency, run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
Trial summary
The lack of a pharmacological treatment in the COVID-19 pandemic has pushed scientists to search for this issue. Maintaining optimal health is parallel to adequate and balanced nutrition. In this context, can the protective properties of vitamin D play an important role in this pandemic? brought with it the thought. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pandemic, Vitamin D Deficiency
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Aug 2021to 16 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with positive COVID-19 PCR (Polymerase Chain Reaction) test and vitamin D level in biochemical parameters, who applied to Ankara City Hospital Neurology-Orthopedics Hospital between 01 August and 31 October 2020.
Who may be able to join
- COVID-19 PCR (Polymerase Chain Reaction) test positive
- Vitamin D level in biochemical parameters
- Adult patients hospitalized for COVID-19
Who cannot join
- -Patients using drugs that may affect vitamin D absorption, such as corticosteroids, cholesterol-lowering agents, phenobarbital and phenytoin-containing agents
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Republic of Turkey Ministry of Health Ankara City Hospitals Neurology-Orthopedics Hospital
Ankara, 06800
About this study
Official title: Vitamin D Level: Reflections of a Public Health Issue in the COVID-19 Pandemic. Does it Affect Mortality and Length of Hospital Stay?
The lack of a pharmacological treatment in the COVID-19 pandemic has pushed scientists to search for this issue. Maintaining optimal health is parallel to adequate and balanced nutrition. In this context, can the protective properties of vitamin D play an important role in this pandemic? brought with it the thought. In this study, it was aimed to examine the effect of vitamin D on mortality and hospital stay in COVID-19 disease.
Read the detailed description
This research was conducted to examine the effect of vitamin D on mortality and hospital stay in COVID-19 disease. For this, the approval of the Ministry of Health and then the ethics committee was obtained. For this reason, patients with positive PCR tests and hospitalized patients with vitamin D levels in their biochemistry were included in the study.
The data of the patients were obtained from the medical records. Information such as age, gender, comorbidities, length of hospital stay, vitamin D level were included in the study. According to the statistical analyzes obtained from these data, it has been shown that vitamin D level has no effect on mortality and hospital stay in COVID-19 disease.
- Conditions
- COVID-19 Pandemic, Vitamin D Deficiency
- Keywords
- COVID-19, Vitamin D, Length of stay, Mortality
- Medical subject headings
- COVID-19, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COVID-19 + with vitamin D levels | Patients with COVID-19 + and vitamin D levels were included in the study retrospectively. Vitamin D level was categorized into 3 groups as inadequacy, deficiency and normal from medical records. No intervention was made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Vitamin D
Vitamin D levels of patients with a diagnosis of COVID-10. These results were categorized at the level of deficiency/insufficiency/normal.
Measured: 1 month later
Relationship between vitamin D level and mortality
Relationship between survival and death by categorized vitamin D level.
Measured: 1 month later
Relationship between vitamin D level and hospital stay
Length of hospital stay by categorized vitamin D level.
Measured: 1 month later
Secondary outcomes (1)
Effects of additional diseases (Diabetes mellitus, hypertension, etc.) on hospital stay and mortality
Evaluation of the impact of comorbidities on survival during COVID-19 disease.
Measured: 1 month later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start21 Aug 2021
- Primary completion9 Nov 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Sevan ÇETİN ÖZBEK, Yuksek Ihtisas University
- Investigators
- Levent Öztürk, MD, Study director, Republic of Turkey Ministry of Health Ankara City Hospitals Neurology-Orthopedics Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221983
- Sponsor's protocol ID
- YuksekIU-SCOZBEK001
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Level: Reflections of a Public Health Issue in the COVID-19 Pandemic. Does it Affect Mortality and Length of Hospital Stay?
- ClinicalTrials.gov ID
- NCT05221983
- Acronym / sponsor ID
- YuksekIU-SCOZBEK001
- Conditions
- COVID-19 Pandemic, Vitamin D Deficiency
- Keywords
- COVID-19, Vitamin D, Length of stay, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 3 Feb 2022 (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.
The lack of a pharmacological treatment in the COVID-19 pandemic has pushed scientists to search for this issue. Maintaining optimal health is parallel to adequate and balanced nutrition. In this context, can the protective properties of vitamin D play an important role in this pandemic? brought with it the thought. In this study, it was aimed to examine the effect of vitamin D on mortality and hospital stay in COVID-19 disease.
Detailed description
This research was conducted to examine the effect of vitamin D on mortality and hospital stay in COVID-19 disease. For this, the approval of the Ministry of Health and then the ethics committee was obtained. For this reason, patients with positive PCR tests and hospitalized patients with vitamin D levels in their biochemistry were included in the study.
The data of the patients were obtained from the medical records. Information such as age, gender, comorbidities, length of hospital stay, vitamin D level were included in the study. According to the statistical analyzes obtained from these data, it has been shown that vitamin D level has no effect on mortality and hospital stay in COVID-19 disease.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID-19 + with vitamin D levels | – | –Patients with COVID-19 + and vitamin D levels were included in the study retrospectively. Vitamin D level was categorized into 3 groups as inadequacy, deficiency and normal from medical records. No intervention was made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with positive COVID-19 PCR (Polymerase Chain Reaction) test and vitamin D level in biochemical parameters, who applied to Ankara City Hospital Neurology-Orthopedics Hospital between 01 August and 31 October 2020.
Key inclusion criteria (3 listed)
- COVID-19 PCR (Polymerase Chain Reaction) test positive
- Vitamin D level in biochemical parameters
- Adult patients hospitalized for COVID-19
Key exclusion criteria (1 listed)
- -Patients using drugs that may affect vitamin D absorption, such as corticosteroids, cholesterol-lowering agents, phenobarbital and phenytoin-containing agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of Vitamin D
Time frame: 1 month later
Vitamin D levels of patients with a diagnosis of COVID-10. These results were categorized at the level of deficiency/insufficiency/normal.
Relationship between vitamin D level and mortality
Time frame: 1 month later
Relationship between survival and death by categorized vitamin D level.
Relationship between vitamin D level and hospital stay
Time frame: 1 month later
Length of hospital stay by categorized vitamin D level.
1 secondary outcome
Effects of additional diseases (Diabetes mellitus, hypertension, etc.) on hospital stay and mortality
Time frame: 1 month later.
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 21 Feb 2022.
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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.
Levent Öztürk, MD study director
Republic of Turkey Ministry of Health Ankara City Hospitals Neurology-Orthopedics Hospital
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 COVID-19 Pandemic and Vitamin D Deficiency, run by Yuksek Ihtisas University 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 3 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 21 Feb 2022. 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?
Level of Vitamin D (time frame: 1 month later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2022.