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

NCT04751721 | Unknown

• 1 other identifier: 2021-01-173
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

There is no effective treatment method for COVID-19 yet. With vaccination being the most effective approach to control the COVID-19 pandemic, vaccines have been developed with many different methods. One of the vaccines developed, the China-based CoronaVac vaccine (inactivated + aluminum adjuvant vaccine) is a vaccine developed with the inactive method, which is the classical vaccine production method. As a result of Phase 1, Phase 2 and Phase 3 trials, 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. In the clinical results of COVID-19, it has been observed that the severity of the disease is lower in women than in men, and the mortality rates are lower in women than in men. A few studies have shown the physiological roles of some vitamins and trace elements in COVID-19. Investigation of free radical levels known to be effective in the development of cardiovascular disease due to oxidative stress is important in determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, the social isolation rules and quarantine measures applied in the COVID-19 pandemic have caused individuals to be negatively affected physically and psychologically and their quality of life to decrease. Investigating the changes in oxidative stress parameters, trace element and quality of life levels of vaccination in COVID-19 may provide useful information in determining the effects of COVID-19 vaccine. It is planned to include female individuals to be vaccinated in Izmir Bakırcay University Cigli Training and Research Hospital. Within the scope of the study, it was planned to determine the oxidative stress parameters, trace element levels and quality of life levels of the individuals and to compare the values of the data obtained 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

Keywords

Covid-19; CoronaVac vaccine; Healthy women

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: female
• 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
• Being pregnant
• 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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

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)