Covid-19 VaccineNCT04751695
Oxidative Stress Parameters, Trace Element and Quality of Life in Men Before and After Covid-19 Vaccines
A study testing CoronoVac Vaccine in people with Covid-19 Vaccine, 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, research on many different drug approaches has begun and these researches continue today. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Covid-19 Vaccine
- What is being tested?
- CoronoVac Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2021to Apr 2021
- Phase
- Interventional
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agree to voluntarily participate in the study
Who cannot join
- Have been taking trace element supplements for the past 2 weeks
- Body mass index over 40 kg/m2
- Diagnosed with Covid-19 in advance
- Not diagnosed with any chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Oxidative Stress Parameters, Trace, Element and Quality of Life Levels in Healthy Men Before and After Covid-19 Vaccines
With the rapid spread of COVID-19 (SARS-CoV-2) disease all over the world and the announcement of a pandemic, research on many different drug approaches has begun and these researches continue today. Although measures such as social distance, quarantine and isolation are effective in reducing the spread of SARS-CoV-2 in the short term during the pandemic, there is no effective treatment method yet. It is known that especially healthcare workers, the elderly and individuals with underlying health problems are at high risk. However, gender differences in COVID-19 clinical outcomes are thought to exist, and there is growing evidence that the disease is more severe in men than in women and mortality rates are higher.With the global consensus that the most effective approach to control the COVID-19 pandemic is a vaccination that is effective in COVID-19, vaccines have been developed with many different methods. CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed with the inactive method, which is the classic vaccine production method. After the completion of Phase 1 and Phase 2 trials of the vaccine, Phase 3 trials were initiated to investigate the effectiveness of the vaccine in 4 different countries, including Turkey. Emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency. Researching the effects of vaccination on oxidative stress parameters, trace element and quality of life levels in COVID-19 may provide useful information in determining the effects of COVID-19 vaccine. 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 oxidative stress, which can provide information on determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, the quality of life of individuals decreases in the COVID-19 pandemic.This study is planned to be carried out by including male individuals to be vaccinated in İzmir Bakırçay University Çiğli Training and Research Hospital. Determination of oxidative stress parameters, trace element levels and quality of life levels before and after vaccination applications to be applied to individuals within the scope of the study; It was planned to compare these data before and after vaccination. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.
Read the detailed description
Coronavirus-2019 (COVID-19) is a global epidemic that has serious consequences and affects the world with its rapid spread and high mortality rate. The number of people infected with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV2) is rapidly increasing. COVID-19 patients may have pneumonia, severe symptoms of Acute Respiratory Distress Syndrome (ARDS) and multiple organ failure, as well as cases with no symptoms.
Although social distance, quarantine and isolation are effective in reducing the spread of SARS-CoV-2 in the short term during the pandemic, there is no effective treatment method yet. It is known that especially healthcare workers, the elderly and individuals with underlying health problems are at high risk. However, gender differences in COVID-19 clinical outcomes are thought to exist, and there is growing evidence that the disease is more severe in men than in women and mortality rates are higher.
The highly contagious nature of SARS-CoV-2 has led to millions of cases worldwide, strengthening the global need for an effective vaccine to halt the spread of the disease and reduce the number of deaths. With the global consensus that the most effective approach to control the COVID-19 pandemic is a vaccination that is effective in COVID-19, many different vaccines have been tested with the acceleration of vaccination studies. According to the data of the World Health Organization, there are 236 vaccines in total, with clinical (63) and pre-clinical (173) studies developed using 10 different methods. Types of vaccines for COVID-19 include conventionally live attenuated viruses, inactivated virus protein or polysaccharide conjugated subunit vaccines, virus-like particles (VLPs), nucleic acid (DNA and RNA), viral vectors (replicating and non-replicating), and and other vaccines consisting of recombinant proteins.
Although the production of virus-based vaccines takes longer than other vaccines, the immune response is expected to be at a good level. Measles, mumps, Hepatitis A and chickenpox vaccines are examples of vaccines developed with the virus-based method. CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed by the inactive method (produced and inactivated by the SARS-CoV-2 virus in the laboratory), which is the classic vaccine production method. China-based vaccine development Sinovac Biotech Ltd. Made by the biopharmaceutical company named. After the completion of Phase 1 and Phase 2 studies of the vaccine, Phase 3 studies were initiated to investigate the effectiveness of the vaccine in 4 different countries, including our country. Emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency.
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.
Some vitamins and nutrients may be beneficial for patients infected with COVID-19 due to their anti-inflammatory and antioxidant properties. 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.
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 leak 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 may result in cancer, neurodegenerative and cardiovascular diseases, diabetes and It constitutes the molecular basis in the development of autoimmune disorders.
With the quarantine measures applied, not going out and staying at home causes the person to stay away from his daily routine life, the increase in the time spent at home, the pandemic news that is constantly being listened to and watched cause increasing anxiety, causing both changes in mood and a more sedentary life . Studies have also reported that negative psychological effects such as post-traumatic stress symptoms, confusion and anger as a result of quarantine have been reported. In addition, it has been said that restriction often causes boredom, disappointment and a feeling of isolation. These consequences, brought about by the COVID-19 pandemic, negatively affect the quality of life of individuals. During the COVID-19 pandemic, it has been reported that the depression and anxiety levels of healthcare workers increased and their quality of life decreased.
The objective of this study is to compare and determined and the changes of oxidative stress parameters, trace element and quality of life levels in healthy men just before the first dose of COVID-19 vaccine and on the 7th day after the second dose of COVID19 vaccine.
- Conditions
- Covid-19 Vaccine
- Being tested
- CoronoVac Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoronoVac VaccineBiological
CoronaVac vaccines will be inoculated in 2 doses with an interval of 24 days.
| Study group | Role | What they receive |
|---|---|---|
| CoronoVac Vaccine Group | Experimental | Not described Receives: Biological: CoronoVac Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the levels of Oxidative Stress Parameter 1
Oxidative Stress Parameter including Superoxide Dismutase (SOD) will be studied by photometric method in Medical Biochemistry Laboratory.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels of Oxidative Stress Parameter 2
Oxidative Stress Parameters including Malondialdehyde (MDA) will be studied by photometric method in Medical Biochemistry Laboratory.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels of Oxidative Stress Parameter 3
Oxidative Stress Parameter including Total Antioxidant Level (TAL) will be studied by photometric method in Medical Biochemistry Laboratory.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels of Oxidative Stress Parameter 4
Oxidative Stress Parameters including Total Oxidant Level (TOL) will be studied by photometric method in Medical Biochemistry Laboratory.
Measured: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 1
Serum trace element including zinc 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: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 2
Serum trace elements including selenium 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: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 3
Serum trace element including potassium 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: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 4
Serum trace element including sodium 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: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 5
Serum trace elements including calcium 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: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 6
Serum trace element including magnesium 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: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels serum trace element 7
Serum trace element including 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: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Change of the levels of quality of life
SF-36 Quality of Life Scale will be used to determine the quality of life level. The scale that patients can apply themselves and in a short time; It consists of 36 items and 8 subsections. These sections are physical functionality, social functionality, role restrictions due to physical problems, role restrictions due to emotional problems, pain, energy level / vitality / vitality, mental health, and general health perception (40). The last 4 weeks are considered in the evaluation of the scale. The scale gives a separate total score for each subsection. The points obtained from the subsections are not added up. Subdivisions rate health from 0 to 100. While it expresses bad health status as "0 points", it refers to good health status as "100 points".
Measured: Immediately before the first dose and 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 VaccineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
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
- NCT04751695
- Sponsor's protocol ID
- 2021-01-174
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 12 Feb 2021
- 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 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxidative Stress Parameters, Trace, Element and Quality of Life Levels in Healthy Men Before and After Covid-19 Vaccines
- ClinicalTrials.gov ID
- NCT04751695
- Acronym / sponsor ID
- 2021-01-174
- Conditions
- Covid-19 Vaccine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Cigli Regional Training Hospital, Muğla Sıtkı Koçman University
- Study start
- Feb 2021 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 12 Feb 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, research on many different drug approaches has begun and these researches continue today. Although measures such as social distance, quarantine and isolation are effective in reducing the spread of SARS-CoV-2 in the short term during the pandemic, there is no effective treatment method yet. It is known that especially healthcare workers, the elderly and individuals with underlying health problems are at high risk. However, gender differences in COVID-19 clinical outcomes are thought to exist, and there is growing evidence that the disease is more severe in men than in women and mortality rates are higher.With the global consensus that the most effective approach to control the COVID-19 pandemic is a vaccination that is effective in COVID-19, vaccines have been developed with many different methods. CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed with the inactive method, which is the classic vaccine production method. After the completion of Phase 1 and Phase 2 trials of the vaccine, Phase 3 trials were initiated to investigate the effectiveness of the vaccine in 4 different countries, including Turkey. Emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency. Researching the effects of vaccination on oxidative stress parameters, trace element and quality of life levels in COVID-19 may provide useful information in determining the effects of COVID-19 vaccine. 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 oxidative stress, which can provide information on determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, the quality of life of individuals decreases in the COVID-19 pandemic.This study is planned to be carried out by including male individuals to be vaccinated in İzmir Bakırçay University Çiğli Training and Research Hospital. Determination of oxidative stress parameters, trace element levels and quality of life levels before and after vaccination applications to be applied to individuals within the scope of the study; It was planned to compare these data before and after vaccination. After analyzing the data obtained from the research with appropriate statistical methods, the data will be evaluated.
Detailed description
Coronavirus-2019 (COVID-19) is a global epidemic that has serious consequences and affects the world with its rapid spread and high mortality rate. The number of people infected with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV2) is rapidly increasing. COVID-19 patients may have pneumonia, severe symptoms of Acute Respiratory Distress Syndrome (ARDS) and multiple organ failure, as well as cases with no symptoms.
Although social distance, quarantine and isolation are effective in reducing the spread of SARS-CoV-2 in the short term during the pandemic, there is no effective treatment method yet. It is known that especially healthcare workers, the elderly and individuals with underlying health problems are at high risk. However, gender differences in COVID-19 clinical outcomes are thought to exist, and there is growing evidence that the disease is more severe in men than in women and mortality rates are higher.
The highly contagious nature of SARS-CoV-2 has led to millions of cases worldwide, strengthening the global need for an effective vaccine to halt the spread of the disease and reduce the number of deaths. With the global consensus that the most effective approach to control the COVID-19 pandemic is a vaccination that is effective in COVID-19, many different vaccines have been tested with the acceleration of vaccination studies. According to the data of the World Health Organization, there are 236 vaccines in total, with clinical (63) and pre-clinical (173) studies developed using 10 different methods. Types of vaccines for COVID-19 include conventionally live attenuated viruses, inactivated virus protein or polysaccharide conjugated subunit vaccines, virus-like particles (VLPs), nucleic acid (DNA and RNA), viral vectors (replicating and non-replicating), and and other vaccines consisting of recombinant proteins.
Although the production of virus-based vaccines takes longer than other vaccines, the immune response is expected to be at a good level. Measles, mumps, Hepatitis A and chickenpox vaccines are examples of vaccines developed with the virus-based method. CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed by the inactive method (produced and inactivated by the SARS-CoV-2 virus in the laboratory), which is the classic vaccine production method. China-based vaccine development Sinovac Biotech Ltd. Made by the biopharmaceutical company named. After the completion of Phase 1 and Phase 2 studies of the vaccine, Phase 3 studies were initiated to investigate the effectiveness of the vaccine in 4 different countries, including our country. Emergency use approval has been given for the CoronaVac vaccine by Turkish Pharmaceuticals and Medical Devices Agency.
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.
Some vitamins and nutrients may be beneficial for patients infected with COVID-19 due to their anti-inflammatory and antioxidant properties. 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.
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 leak 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 may result in cancer, neurodegenerative and cardiovascular diseases, diabetes and It constitutes the molecular basis in the development of autoimmune disorders.
With the quarantine measures applied, not going out and staying at home causes the person to stay away from his daily routine life, the increase in the time spent at home, the pandemic news that is constantly being listened to and watched cause increasing anxiety, causing both changes in mood and a more sedentary life . Studies have also reported that negative psychological effects such as post-traumatic stress symptoms, confusion and anger as a result of quarantine have been reported. In addition, it has been said that restriction often causes boredom, disappointment and a feeling of isolation. These consequences, brought about by the COVID-19 pandemic, negatively affect the quality of life of individuals. During the COVID-19 pandemic, it has been reported that the depression and anxiety levels of healthcare workers increased and their quality of life decreased.
The objective of this study is to compare and determined and the changes of oxidative stress parameters, trace element and quality of life levels in healthy men just before the first dose of COVID-19 vaccine and on the 7th day after the second dose of COVID19 vaccine.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoronoVac Vaccine Group | Experimental | Biological: CoronoVac Vaccine |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Agree to voluntarily participate in the study
Key exclusion criteria (4 listed)
- Have been taking trace element supplements for the past 2 weeks
- Body mass index over 40 kg/m2
- Diagnosed with Covid-19 in advance
- Not diagnosed with any chronic disease
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 |
|---|---|---|
| CoronoVac VaccineCoronaVac vaccines will be inoculated in 2 doses with an interval of 24 days. | Biological | CoronoVac Vaccine Group |
Primary outcome
Change of the levels of Oxidative Stress Parameter 1
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Oxidative Stress Parameter including Superoxide Dismutase (SOD) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels of Oxidative Stress Parameter 2
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Oxidative Stress Parameters including Malondialdehyde (MDA) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels of Oxidative Stress Parameter 3
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Oxidative Stress Parameter including Total Antioxidant Level (TAL) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels of Oxidative Stress Parameter 4
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Oxidative Stress Parameters including Total Oxidant Level (TOL) will be studied by photometric method in Medical Biochemistry Laboratory.
Change of the levels serum trace element 1
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace element including zinc 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 the levels serum trace element 2
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace elements including selenium 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 the levels serum trace element 3
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace element including potassium 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 the levels serum trace element 4
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace element including sodium 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 the levels serum trace element 5
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace elements including calcium 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 the levels serum trace element 6
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace element including magnesium 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 the levels serum trace element 7
Time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
Serum trace element including 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 the levels of quality of life
Time frame: Immediately before the first dose and 4 weeks later
SF-36 Quality of Life Scale will be used to determine the quality of life level. The scale that patients can apply themselves and in a short time; It consists of 36 items and 8 subsections. These sections are physical functionality, social functionality, role restrictions due to physical problems, role restrictions due to emotional problems, pain, energy level / vitality / vitality, mental health, and general health perception (40). The last 4 weeks are considered in the evaluation of the scale. The scale gives a separate total score for each subsection. The points obtained from the subsections are not added up. Subdivisions rate health from 0 to 100. While it expresses bad health status as "0 points", it refers to good health status as "100 points".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
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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?
A study testing CoronoVac Vaccine in people with Covid-19 Vaccine, 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 1 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: status not confirmed, as of the sponsor's last update on 12 Feb 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?
Results are not available in the source record.
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 Oxidative Stress Parameter 1 (time frame: Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine). The study lists 12 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 12 Feb 2021.