Oxidative Stress Parameters, Trace Element and Quality of Life in Men Before and After Covid-19 Vaccines

NCT04751695 | Unknown

• 1 other identifier: 2021-01-174
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Covid-19 Vaccine

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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".

  Immediately before the first dose and 4 weeks later

Study Arms (1)

CoronoVac Vaccine Group

EXPERIMENTAL

Biological: CoronoVac Vaccine

Interventions

CoronoVac Vaccine BIOLOGICAL

CoronaVac vaccines will be inoculated in 2 doses with an interval of 24 days.

CoronoVac Vaccine Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to voluntarily participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Bakircay University: lead
• Cigli Regional Training Hospital: collaborator
• Muğla Sıtkı Koçman University: collaborator

Study Sites (1)

Kadirhan Ozdemir

Izmir, 06580, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: February 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

TU (1)