Oxidative Stress Parameters, Trace Element and Quality of Life in Men Before and After Covid-19 Vaccines
Comparison of Oxidative Stress Parameters, Trace, Element and Quality of Life Levels in Healthy Men Before and After Covid-19 Vaccines
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
İzmir, Turkey, 06580
- Kadirhan Ozdemir
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Agree to voluntarily participate in the study
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: CoronoVac Vaccine Group
|
CoronaVac vaccines will be inoculated in 2 doses with an interval of 24 days.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
|
|
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.
|
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
|
|
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.
|
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
|
|
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.
|
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
|
|
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.
|
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
|
|
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.
|
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
|
|
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.
|
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
|
|
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.
|
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
|
|
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.
|
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
|
|
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.
|
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
|
|
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".
|
Immediately before the first dose and 4 weeks later
|
|
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
|
Immediately before the first dose and 7 days after the second dose of CoronaVac vaccine
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2021-01-174
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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