Covid19NCT04694716
Determination of Serum Trace Element and Physical Activity Levels in COVID-19
An observational study of Covid19, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
The pathogenesis of COVID-19, which is caused by the coronavirus species, which has become a global health problem affecting the lives of billions of people worldwide and is a member of the Betacoronavirus genus, is not fully understood. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2021to 15 Aug 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants in Group I will be included the study from Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital). Participants in Group II will be included the study from community sample.
Who may be able to join
- Having a diagnosis of COVID-19 for Group I,
- Not having any chronic diseases for Group II,
Who cannot join
- Having been taking trace element supplements for the last 2 weeks
- Patients who do not require hospitalization for Group I,
- Patients with a diagnosis of kidney failure and/or heart failure for Group I,
- Patients who are pregnant for Group I
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Serum Trace Element and Physical Activity Levels in COVID-19 Patients
The pathogenesis of COVID-19, which is caused by the coronavirus species, which has become a global health problem affecting the lives of billions of people worldwide and is a member of the Betacoronavirus genus, is not fully understood. Although its pathogenesis is thought to be multifactorial, it results in a systemic hyperinflammatory response and associated thromboembolic complications in severe cases. It is thought that some vitamins and nutrients may be beneficial for COVID-19 infected patients due to their anti-inflammatory and antioxidant properties. Vitamins such as A, B, C, D, E and folate; trace elements such as iron, zinc, magnesium, selenium and copper play important roles in supporting both innate and adaptive immune systems, and studies have shown that the trace elements investigated have important roles in COVID-19. For this reason, it is important to investigate the levels of trace elements. In addition, while the disease spreads all over the world, individuals are required to stay at home for a long time against the risk of contamination. Due to these isolation and limitations, physical activity levels decrease in individuals. As reductions in the level of physical activity may cause possible secondary symptoms, another parameter is to determine the physical activity level in order to prevent the potential harmful effects of these protective lifestyle regulations related to COVID-19 and to prevent the restrictions from causing physical inactivity. This study is planning to conduct between January and February 2021 in order to compare the trace element levels in blood samples and physical activity levels of patients with COVID-19 (SARS CoV-2) who applied to Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital) and hospitalized in the COVID-19 service. It was planned as a prospective, randomized controlled trial. Research data will be obtained from blood samples taken from participants. In addition, data on physical activity levels will be collected through a questionnaire. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.
Read the detailed description
Coronavirus disease 2019 (COVID-19), also known as Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), is caused by a coronavirus strain that has become a global health problem by affecting the lives of billions of people worldwide and is a member of the Betacoronavirus genus.
Its clinical presentation can be heterogeneous, ranging from asymptomatic to severe disease, which may be associated with a cytokine storm. The pathogenesis of COVID-19 is not fully understood, but it is likely multifactorial, resulting in a systemic hyperinflammatory response and associated thromboembolic complications in severe cases.
Due to their anti-inflammatory and antioxidant properties, certain vitamins and nutrients may be beneficial for patients infected with COVID-19. Vitamins such as A, B, C, D, E and folate; Trace elements such as iron, zinc, magnesium, selenium and copper have important roles in supporting both innate and adaptive immune systems.
In order to consider an adult to be physically active, it is generally accepted to reach at least 150 minutes of moderate or 75 minutes of high-intensity activity per week, or an equivalent combination of both. Sedentary behavior is defined as wakeful behavior characterized by an energy expenditure of less than 1.5 metabolic equivalent (MET) in positions such as lying, sitting or standing. While the COVID-19 disease spreads all over the world, healthy people are asked to stay at home for a long time against the risk of transmission. As a result, COVID-19 is radically changing the determinants of both behaviors (individual, interpersonal, environmental, regional or national policies and global). Accordingly, it can be said that due to isolation and limitations in regular and joint activities, it can be said that it poses a significant challenge to fulfill physical activity recommendations and reduce sedentary behavior during the stay at home, especially in the first weeks when the chance of finding alternatives to keep the population active even at home is limited. For this reason, individuals are strongly encouraged to engage in physical activity in the home environment by public health advocates to prevent the potential harmful effects of protective lifestyle regulations related to COVID-19 and to prevent the restrictions from causing physical inactivity.
In the light of all this information, in order to contribute to the literature, the aim of this study is to determine the serum trace element levels and physical activity levels of COVID-19 patients immediately before the beginning of COVID-19 treatments and compare with the results of healthy adults.
- Conditions
- Covid19
- Being tested
- No intervention
- Keywords
- Covid-19 (SARS-CoV-2), Serum trace elements, Physical activity
- Medical subject headings
- COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 group (Group I) | Patients diagnosed with Covid-19 will be enrolled in this group. Receives: Other: No intervention | |
| Control group (Group II) | Healthy individuals will be enrolled in this group. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of serum trace elements parameters
Serum trace elements (zinc, selenium, potassium, sodium, calcium, magnesium, copper) levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Measured: At baseline
Physical Activity Level
International Physical Activity Questionnaire will be used to determine the level of physical activity.
Measured: At baseline
Secondary outcomes (1)
Levels of Routine Blood Samples
Hemogram, levels of vitamin D, Troponin T, D-Dimer, iron, ferritin, C-reactive protein (CRP), lymphocyte/CRP ratio, neutrophil/lymphocyte ratio, levels of procalcitonin, uric acid, chlorine, blood urea nitrogen (BUN) creatine, albumin and bilirubin will be taken from patient files.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start6 Jan 2021
- Primary completion15 May 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Cigli Regional Training Hospital, Muğla Sıtkı Koçman University
- Responsible party
- Principal investigator, Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694716
- Sponsor's protocol ID
- 2020-12-141
- Status last verified
- Aug 2021
- First submitted
- 3 Jan 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Serum Trace Element and Physical Activity Levels in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04694716
- Acronym / sponsor ID
- 2020-12-141
- Conditions
- Covid19
- Keywords
- Covid-19 (SARS-CoV-2), Serum trace elements, Physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Cigli Regional Training Hospital, Muğla Sıtkı Koçman University
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 5 Jan 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.
The pathogenesis of COVID-19, which is caused by the coronavirus species, which has become a global health problem affecting the lives of billions of people worldwide and is a member of the Betacoronavirus genus, is not fully understood. Although its pathogenesis is thought to be multifactorial, it results in a systemic hyperinflammatory response and associated thromboembolic complications in severe cases. It is thought that some vitamins and nutrients may be beneficial for COVID-19 infected patients due to their anti-inflammatory and antioxidant properties. Vitamins such as A, B, C, D, E and folate; trace elements such as iron, zinc, magnesium, selenium and copper play important roles in supporting both innate and adaptive immune systems, and studies have shown that the trace elements investigated have important roles in COVID-19. For this reason, it is important to investigate the levels of trace elements. In addition, while the disease spreads all over the world, individuals are required to stay at home for a long time against the risk of contamination. Due to these isolation and limitations, physical activity levels decrease in individuals. As reductions in the level of physical activity may cause possible secondary symptoms, another parameter is to determine the physical activity level in order to prevent the potential harmful effects of these protective lifestyle regulations related to COVID-19 and to prevent the restrictions from causing physical inactivity. This study is planning to conduct between January and February 2021 in order to compare the trace element levels in blood samples and physical activity levels of patients with COVID-19 (SARS CoV-2) who applied to Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital) and hospitalized in the COVID-19 service. It was planned as a prospective, randomized controlled trial. Research data will be obtained from blood samples taken from participants. In addition, data on physical activity levels will be collected through a questionnaire. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.
Detailed description
Coronavirus disease 2019 (COVID-19), also known as Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), is caused by a coronavirus strain that has become a global health problem by affecting the lives of billions of people worldwide and is a member of the Betacoronavirus genus.
Its clinical presentation can be heterogeneous, ranging from asymptomatic to severe disease, which may be associated with a cytokine storm. The pathogenesis of COVID-19 is not fully understood, but it is likely multifactorial, resulting in a systemic hyperinflammatory response and associated thromboembolic complications in severe cases.
Due to their anti-inflammatory and antioxidant properties, certain vitamins and nutrients may be beneficial for patients infected with COVID-19. Vitamins such as A, B, C, D, E and folate; Trace elements such as iron, zinc, magnesium, selenium and copper have important roles in supporting both innate and adaptive immune systems.
In order to consider an adult to be physically active, it is generally accepted to reach at least 150 minutes of moderate or 75 minutes of high-intensity activity per week, or an equivalent combination of both. Sedentary behavior is defined as wakeful behavior characterized by an energy expenditure of less than 1.5 metabolic equivalent (MET) in positions such as lying, sitting or standing. While the COVID-19 disease spreads all over the world, healthy people are asked to stay at home for a long time against the risk of transmission. As a result, COVID-19 is radically changing the determinants of both behaviors (individual, interpersonal, environmental, regional or national policies and global). Accordingly, it can be said that due to isolation and limitations in regular and joint activities, it can be said that it poses a significant challenge to fulfill physical activity recommendations and reduce sedentary behavior during the stay at home, especially in the first weeks when the chance of finding alternatives to keep the population active even at home is limited. For this reason, individuals are strongly encouraged to engage in physical activity in the home environment by public health advocates to prevent the potential harmful effects of protective lifestyle regulations related to COVID-19 and to prevent the restrictions from causing physical inactivity.
In the light of all this information, in order to contribute to the literature, the aim of this study is to determine the serum trace element levels and physical activity levels of COVID-19 patients immediately before the beginning of COVID-19 treatments and compare with the results of healthy adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 group (Group I) | – | Other: No interventionPatients diagnosed with Covid-19 will be enrolled in this group. |
| Control group (Group II) | – | Other: No interventionHealthy individuals will be enrolled in this group. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in Group I will be included the study from Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital). Participants in Group II will be included the study from community sample.
Key inclusion criteria (2 listed)
- Having a diagnosis of COVID-19 for Group I,
- Not having any chronic diseases for Group II,
Key exclusion criteria (4 listed)
- Having been taking trace element supplements for the last 2 weeks
- Patients who do not require hospitalization for Group I,
- Patients with a diagnosis of kidney failure and/or heart failure for Group I,
- Patients who are pregnant for Group I
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 |
|---|---|---|
| No interventionNo intervention will be applied. | Other | Control group (Group II), Covid-19 group (Group I) |
Primary outcome
Levels of serum trace elements parameters
Time frame: At baseline
Serum trace elements (zinc, selenium, potassium, sodium, calcium, magnesium, copper) levels will be determined by venous blood samples taken from the participants. Serum trace element levels samples will be analyzed using the atomic absorption spectrophotometry (AAS) method.
Physical Activity Level
Time frame: At baseline
International Physical Activity Questionnaire will be used to determine the level of physical activity.
1 secondary outcome
Levels of Routine Blood Samples
Time frame: At baseline
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 31 Aug 2021.
- Individual participant dataSharing planned: No
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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 Covid19, run by Izmir Bakircay 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 2 inclusion and 4 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 31 Aug 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?
Levels of serum trace elements parameters (time frame: At baseline). The study lists 2 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 31 Aug 2021.