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

NCT04751721 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-02-12

No results posted yet for this study

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

Interventions

BIOLOGICAL

CoronoVac Vaccine

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

Sponsors & Collaborators

  • Cigli Regional Training Hospital

    collaborator OTHER

  • Muğla Sıtkı Koçman University

    collaborator OTHER

  • Izmir Bakircay University

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2021-03-31
Completion
2021-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04751721 on ClinicalTrials.gov