Covid19NCT04694703
Changing of Trace Element, Homocysteine, Oxidative Stress Parameters 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
With the rapid spread of COVID-19 (SARS-CoV-2) disease all over the world and the announcement of a pandemic, researches on many different drug approaches have begun and these researches continue today. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- Covid-19 group
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2021to 29 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
- Adult, Older adult
Study population: Participants in Group I and Group II will be included the study from Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital).
Who may be able to join
- To agree to participate in the study voluntarily,
- Having a diagnosis of COVID-19,
Who cannot join
- Having been taking trace element supplements for the last 2 weeks and/or currently,
- Patients who do not need hospitalization,
- Having a diagnosis of kidney failure and/or heart failure,
- Being pregnant,
- Body mass index over 40 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changing of Trace Element, Homocysteine, Oxidative Stress Parameters and Physical Activity Levels in Patients Diagnosed With COVID-19 Before and After COVID-19 Treatment
With the rapid spread of COVID-19 (SARS-CoV-2) disease all over the world and the announcement of a pandemic, researches on many different drug approaches have begun and these researches continue today. Considering the absence of a specific treatment for the disease yet and the urgency of the situation, drugs previously licensed for the treatment of other diseases and thought to be effective in COVID-19 have started to be used. Ongoing studies are conducted on the effectiveness, possible side effects and safety of these drugs in COVID-19, but there is no clear information yet. It is thought that the anti-inflammatory and antioxidant properties of some vitamins and trace elements may be associated with positive results in COVID-19 patients, and the physiological roles of these vitamins and trace elements in COVID 19 have been demonstrated by studies. It is important to investigate the levels of free radicals known to be effective in the development of cardiovascular disease due to homocysteine and oxidative stress, which can provide information on determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, as the decrease in physical activity levels of individuals in the COVID-19 pandemic may cause possible secondary complications such as an increase in the risk of cardiovascular disease, determining the physical activity levels of individuals and encouraging them to physical activity is another important parameter to minimize the negative effects of the process. It is thought that investigating the effects of the treatment approaches used in COVID-19 on trace element, homocysteine, oxidative stress parameters and physical activity levels will provide useful information in determining the factors underlying better clinical results. This study was planned to be carried out between 6-31 January 2021 in order to compare the trace element, homocysteine, oxidative stress parameters and physical activity levels before and after treatment for COVID-19 disease in COVID-19 patients who applied to Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital) and hospitalized in the COVID-19 service. 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
Since December 2019, the new severe acute respiratory syndrome coronavirus 2, called SARS-CoV-2, has spread rapidly to almost every country that causes coronavirus disease-19 (COVID-19) pneumonia. Currently, there is no specific treatment for COVID-19 with proven safety and effectiveness. In order to find an effective treatment for this disease, more than 100 randomized controlled trials are currently being conducted with many drugs, some of them are expected to be announced in the coming months. It is known that the use of treatment options within the framework of randomized controlled studies and based on information obtained from other scientific studies is more rational. However, due to the urgency of the current situation and the limited scientific data, treatment options with limited data on their effectiveness are widely used for these patients all over the world. As in general of viral infections, the data obtained from SARS and influenza suggest that early initiation of antiviral treatment is more beneficial, and antiviral drugs should be started as early as possible. The combined use of possible treatment options in COVID-19 patients should be considered on a patient-specific basis and by evaluating all the relevant literature, and attention should be paid to the interactions and adverse effects of the drugs used.
Since it will take a long time to find a treatment specific to COVID-19, during the current pandemic, drugs such as hydroxychloroquine, favipiravir, remdesivir, lopinavir-ritonavir, which have been previously licensed for the treatment of other diseases in humans, have been widely used in these indications, have been shown to be safe and are effective in SARS CoV-2 in vitro, have been recommended and used. Numerous studies are still ongoing on the efficacy and safety of these drugs in COVID-19.
The clinical picture of COVID-19 can be heterogeneous, ranging from asymptomatic to severe disease, which can be associated with a cytokine storm. The pathogenesis of COVID-19 is not fully understood, but is likely multifactorial and, in severe cases, with a systemic hyperinflammatory response and associated thromboembolic complications.
It may be beneficial for patients infected with COVID-19 due to the anti-inflammatory and antioxidant properties of certain vitamins and nutrients. Vitamins such as A, B, C, D, E and folate and trace elements such as iron, zinc, magnesium, selenium and copper play important roles in supporting both innate and adaptive immune systems.
High plasma homocysteine levels significantly increase the incidence of vascular damage in both small and large vessels. Concentrations above the 90th percentile are associated with an increased risk of degenerative and atherosclerotic processes in the coronary, cerebral and peripheral circulatory systems. Although homocysteine is an effective cardiovascular risk biomarker and is critical for cardiovascular complications in hospitalized COVID-19 patients, studies on this parameter have not focused much on laboratory markers useful for clinical evaluation of COVID-19.
Free radicals are continuously formed at the active site of enzymes as intermediates in enzymatic reactions occurring during cell metabolism. Reactive oxygen species and reactive nitrogen, known as intermediates, sometimes leach from the active site of enzymes and accidentally interact with molecular oxygen and form free oxygen radicals. Lipids, proteins, enzymes, carbohydrates, and DNA can be damaged due to oxidative stress, random breaks and bonds in DNA chains may occur as a result of damage to membranes, damage to enzymes and structural proteins may result in cell death, and these phenomena constitute the molecular basis in the development of cancer, neurodegenerative and cardiovascular diseases, diabetes and autoimmune disorders.
The general recommendation for thinking that an adult is physically active is to achieve at least 150 minutes of moderate or 75 minutes of vigorous vigorous activity per week, or an equivalent combination of both, and involving sedentary behavior, energy expenditure ≤ 1.5 metabolic equivalent (MET), while lying down, leaning, It is defined as any waking behavior practiced while sitting or standing. As the disease spreads all over the world, healthy people are asked to stay at home for a long time. As a result, COVID-19 has radically changed the determinants of both behaviors (individual, interpersonal, environmental, regional or national policies and global). Accordingly, it can be said that regular and joint activities decrease due to isolation and limitations, especially in the first weeks when the population has limited chances to find alternatives to keep active even at home, and reducing sedentary behavior during closure poses a significant challenge. Because of this situation, physical activity in the home environment is strongly encouraged by public health advocates to prevent the potential harmful effects of protective lifestyle regulations due to COVID-19 and to prevent the restrictions from causing physical inactivity.
The purpose of this study is to compare the trace element, homocysteine, oxidative stress parameters and physical activity levels before and after COVID-19 treatment according to the COVID-19 treatment guide published by Ministry of Health, Republic of Turkey.
- Conditions
- Covid19
- Being tested
- Covid-19 group
- Keywords
- Covid-19 (SARS-CoV-2), Trace element, Homocystein, Oxidative stress parameters, Physical activity level
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 groupDrug
Routine COVID-19 treatment
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 group | Patients diagnosed with COVID-19 will be enrolled in this group. Receives: Drug: Covid-19 group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the levels of Trace Element at baseline and discharge
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 and immediately before the discharge
Change of Physical Activity Level at baseline and discharge
International Physical Activity Questionnaire will be used to determine the level of physical activity.
Measured: At baseline and immediately before the discharge
Change of the levels of Homocystein at baseline and discharge
Homocystein levels will be studied by using Enzyme Chemiluminescence Immunoassay (ECLIA) in Medical Biochemistry Laboratory.
Measured: At baseline and immediately before the discharge
Change of the levels of Oxidative Stress Parameters at baseline and discharge
Oxidative Stress Parameters including Superoxide Dismutase (SOD), Malondialdehyde (MDA), Total Antioxidant Level (TAL) / Total Oxidant Level (TOL) will be studied by photometric method in Medical Biochemistry Laboratory.
Measured: At baseline and immediately before the discharge
Secondary outcomes (4)
Change of the levels of Routine Blood Samples (Hemogram) at baseline and discharge
Hemogram results will be taken from patient files.
Measured: At baseline and immediately before the discharge
Change of the levels of Routine Blood Samples (vitamin D, Troponin T, D-Dimer, iron and ferritin) at baseline and discharge
Levels of vitamin D, Troponin T, D-Dimer, iron and ferritin will be taken from patient files.
Measured: At baseline and immediately before the discharge
Change of the levels of Routine Blood Samples (C-reactive protein (CRP) and procalcitonin) at baseline and discharge
Levels of C-reactive protein (CRP) and procalcitonin will be taken from patient files.
Measured: At baseline and immediately before the discharge
Change of the levels of Routine Blood Samples (uric acid, chlorine, blood urea nitrogen (BUN) creatine, albumin and bilirubin) at baseline and discharge
Levels of uric acid, chlorine, blood urea nitrogen (BUN) creatine, albumin and bilirubin will be taken from patient files.
Measured: At baseline and immediately before the discharge
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 Jul 2021
- Study completion29 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
- 15 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
- NCT04694703
- Sponsor's protocol ID
- 2020-12-142
- Status last verified
- Sep 2021
- First submitted
- 3 Jan 2021
- Last updated
- 16 Sep 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing of Trace Element, Homocysteine, Oxidative Stress Parameters and Physical Activity Levels in Patients Diagnosed With COVID-19 Before and After COVID-19 Treatment
- ClinicalTrials.gov ID
- NCT04694703
- Acronym / sponsor ID
- 2020-12-142
- Conditions
- Covid19
- Keywords
- Covid-19 (SARS-CoV-2), Trace element, Homocystein, Oxidative stress parameters, Physical activity level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 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 Jul 2021 (actual)
- Study completion
- 29 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.
With the rapid spread of COVID-19 (SARS-CoV-2) disease all over the world and the announcement of a pandemic, researches on many different drug approaches have begun and these researches continue today. Considering the absence of a specific treatment for the disease yet and the urgency of the situation, drugs previously licensed for the treatment of other diseases and thought to be effective in COVID-19 have started to be used. Ongoing studies are conducted on the effectiveness, possible side effects and safety of these drugs in COVID-19, but there is no clear information yet. It is thought that the anti-inflammatory and antioxidant properties of some vitamins and trace elements may be associated with positive results in COVID-19 patients, and the physiological roles of these vitamins and trace elements in COVID 19 have been demonstrated by studies. It is important to investigate the levels of free radicals known to be effective in the development of cardiovascular disease due to homocysteine and oxidative stress, which can provide information on determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, as the decrease in physical activity levels of individuals in the COVID-19 pandemic may cause possible secondary complications such as an increase in the risk of cardiovascular disease, determining the physical activity levels of individuals and encouraging them to physical activity is another important parameter to minimize the negative effects of the process. It is thought that investigating the effects of the treatment approaches used in COVID-19 on trace element, homocysteine, oxidative stress parameters and physical activity levels will provide useful information in determining the factors underlying better clinical results. This study was planned to be carried out between 6-31 January 2021 in order to compare the trace element, homocysteine, oxidative stress parameters and physical activity levels before and after treatment for COVID-19 disease in COVID-19 patients who applied to Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital) and hospitalized in the COVID-19 service. 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
Since December 2019, the new severe acute respiratory syndrome coronavirus 2, called SARS-CoV-2, has spread rapidly to almost every country that causes coronavirus disease-19 (COVID-19) pneumonia. Currently, there is no specific treatment for COVID-19 with proven safety and effectiveness. In order to find an effective treatment for this disease, more than 100 randomized controlled trials are currently being conducted with many drugs, some of them are expected to be announced in the coming months. It is known that the use of treatment options within the framework of randomized controlled studies and based on information obtained from other scientific studies is more rational. However, due to the urgency of the current situation and the limited scientific data, treatment options with limited data on their effectiveness are widely used for these patients all over the world. As in general of viral infections, the data obtained from SARS and influenza suggest that early initiation of antiviral treatment is more beneficial, and antiviral drugs should be started as early as possible. The combined use of possible treatment options in COVID-19 patients should be considered on a patient-specific basis and by evaluating all the relevant literature, and attention should be paid to the interactions and adverse effects of the drugs used.
Since it will take a long time to find a treatment specific to COVID-19, during the current pandemic, drugs such as hydroxychloroquine, favipiravir, remdesivir, lopinavir-ritonavir, which have been previously licensed for the treatment of other diseases in humans, have been widely used in these indications, have been shown to be safe and are effective in SARS CoV-2 in vitro, have been recommended and used. Numerous studies are still ongoing on the efficacy and safety of these drugs in COVID-19.
The clinical picture of COVID-19 can be heterogeneous, ranging from asymptomatic to severe disease, which can be associated with a cytokine storm. The pathogenesis of COVID-19 is not fully understood, but is likely multifactorial and, in severe cases, with a systemic hyperinflammatory response and associated thromboembolic complications.
It may be beneficial for patients infected with COVID-19 due to the anti-inflammatory and antioxidant properties of certain vitamins and nutrients. Vitamins such as A, B, C, D, E and folate and trace elements such as iron, zinc, magnesium, selenium and copper play important roles in supporting both innate and adaptive immune systems.
High plasma homocysteine levels significantly increase the incidence of vascular damage in both small and large vessels. Concentrations above the 90th percentile are associated with an increased risk of degenerative and atherosclerotic processes in the coronary, cerebral and peripheral circulatory systems. Although homocysteine is an effective cardiovascular risk biomarker and is critical for cardiovascular complications in hospitalized COVID-19 patients, studies on this parameter have not focused much on laboratory markers useful for clinical evaluation of COVID-19.
Free radicals are continuously formed at the active site of enzymes as intermediates in enzymatic reactions occurring during cell metabolism. Reactive oxygen species and reactive nitrogen, known as intermediates, sometimes leach from the active site of enzymes and accidentally interact with molecular oxygen and form free oxygen radicals. Lipids, proteins, enzymes, carbohydrates, and DNA can be damaged due to oxidative stress, random breaks and bonds in DNA chains may occur as a result of damage to membranes, damage to enzymes and structural proteins may result in cell death, and these phenomena constitute the molecular basis in the development of cancer, neurodegenerative and cardiovascular diseases, diabetes and autoimmune disorders.
The general recommendation for thinking that an adult is physically active is to achieve at least 150 minutes of moderate or 75 minutes of vigorous vigorous activity per week, or an equivalent combination of both, and involving sedentary behavior, energy expenditure ≤ 1.5 metabolic equivalent (MET), while lying down, leaning, It is defined as any waking behavior practiced while sitting or standing. As the disease spreads all over the world, healthy people are asked to stay at home for a long time. As a result, COVID-19 has radically changed the determinants of both behaviors (individual, interpersonal, environmental, regional or national policies and global). Accordingly, it can be said that regular and joint activities decrease due to isolation and limitations, especially in the first weeks when the population has limited chances to find alternatives to keep active even at home, and reducing sedentary behavior during closure poses a significant challenge. Because of this situation, physical activity in the home environment is strongly encouraged by public health advocates to prevent the potential harmful effects of protective lifestyle regulations due to COVID-19 and to prevent the restrictions from causing physical inactivity.
The purpose of this study is to compare the trace element, homocysteine, oxidative stress parameters and physical activity levels before and after COVID-19 treatment according to the COVID-19 treatment guide published by Ministry of Health, Republic of Turkey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 group | – | Drug: Covid-19 groupPatients diagnosed with COVID-19 will be enrolled in this group. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants in Group I and Group II will be included the study from Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital).
Key inclusion criteria (2 listed)
- To agree to participate in the study voluntarily,
- Having a diagnosis of COVID-19,
Key exclusion criteria (5 listed)
- Having been taking trace element supplements for the last 2 weeks and/or currently,
- Patients who do not need hospitalization,
- Having a diagnosis of kidney failure and/or heart failure,
- Being pregnant,
- Body mass index over 40 kg/m2
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 |
|---|---|---|
| Covid-19 groupRoutine COVID-19 treatment | Drug | Covid-19 group |
Primary outcome
Change of the levels of Trace Element at baseline and discharge
Time frame: At baseline and immediately before the discharge
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.
Change of Physical Activity Level at baseline and discharge
Time frame: At baseline and immediately before the discharge
International Physical Activity Questionnaire will be used to determine the level of physical activity.
Change of the levels of Homocystein at baseline and discharge
Time frame: At baseline and immediately before the discharge
Homocystein levels will be studied by using Enzyme Chemiluminescence Immunoassay (ECLIA) in Medical Biochemistry Laboratory.
Change of the levels of Oxidative Stress Parameters at baseline and discharge
Time frame: At baseline and immediately before the discharge
Oxidative Stress Parameters including Superoxide Dismutase (SOD), Malondialdehyde (MDA), Total Antioxidant Level (TAL) / Total Oxidant Level (TOL) will be studied by photometric method in Medical Biochemistry Laboratory.
4 secondary outcomes
Change of the levels of Routine Blood Samples (Hemogram) at baseline and discharge
Time frame: At baseline and immediately before the discharge
Change of the levels of Routine Blood Samples (vitamin D, Troponin T, D-Dimer, iron and ferritin) at baseline and discharge
Time frame: At baseline and immediately before the discharge
Change of the levels of Routine Blood Samples (C-reactive protein (CRP) and procalcitonin) at baseline and discharge
Time frame: At baseline and immediately before the discharge
Change of the levels of Routine Blood Samples (uric acid, chlorine, blood urea nitrogen (BUN) creatine, albumin and bilirubin) at baseline and discharge
Time frame: At baseline and immediately before the discharge
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 16 Sep 2021.
- Adult Patient Treatment Guide for COVID-19 (Ministry of Health, Republic of Turkey)Link provided by the sponsor.
- 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 5 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 16 Sep 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?
Change of the levels of Trace Element at baseline and discharge (time frame: At baseline and immediately before the discharge). The study lists 4 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 16 Sep 2021.