Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04694716 |
| Other study ID # |
2020-12-141 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 6, 2021 |
| Est. completion date |
August 15, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Izmir Bakircay University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The pathogenesis of COVID-19, which is caused by the coronavirus species, which has become a
global health problem affecting the lives of billions of people worldwide and is a member of
the Betacoronavirus genus, is not fully understood. Although its pathogenesis is thought to
be multifactorial, it results in a systemic hyperinflammatory response and associated
thromboembolic complications in severe cases. It is thought that some vitamins and nutrients
may be beneficial for COVID-19 infected patients due to their anti-inflammatory and
antioxidant properties. Vitamins such as A, B, C, D, E and folate; trace elements such as
iron, zinc, magnesium, selenium and copper play important roles in supporting both innate and
adaptive immune systems, and studies have shown that the trace elements investigated have
important roles in COVID-19. For this reason, it is important to investigate the levels of
trace elements. In addition, while the disease spreads all over the world, individuals are
required to stay at home for a long time against the risk of contamination. Due to these
isolation and limitations, physical activity levels decrease in individuals. As reductions in
the level of physical activity may cause possible secondary symptoms, another parameter is to
determine the physical activity level in order to prevent the potential harmful effects of
these protective lifestyle regulations related to COVID-19 and to prevent the restrictions
from causing physical inactivity. This study is planning to conduct between January and
February 2021 in order to compare the trace element levels in blood samples and physical
activity levels of patients with COVID-19 (SARS CoV-2) who applied to Izmir Bakircay
University Cigli Training and Research Hospital (Cigli Regional Training Hospital) and
hospitalized in the COVID-19 service. It was planned as a prospective, randomized controlled
trial. Research data will be obtained from blood samples taken from participants. In
addition, data on physical activity levels will be collected through a questionnaire. After
analyzing the data obtained from the research with appropriate statistical methods, the data
will be evaluated.
Description:
Coronavirus disease 2019 (COVID-19), also known as Severe Acute Respiratory Syndrome
Coronavirus-2 (SARS-CoV-2), is caused by a coronavirus strain that has become a global health
problem by affecting the lives of billions of people worldwide and is a member of the
Betacoronavirus genus.
Its clinical presentation can be heterogeneous, ranging from asymptomatic to severe disease,
which may be associated with a cytokine storm. The pathogenesis of COVID-19 is not fully
understood, but it is likely multifactorial, resulting in a systemic hyperinflammatory
response and associated thromboembolic complications in severe cases.
Due to their anti-inflammatory and antioxidant properties, certain vitamins and nutrients may
be beneficial for patients infected with COVID-19. Vitamins such as A, B, C, D, E and folate;
Trace elements such as iron, zinc, magnesium, selenium and copper have important roles in
supporting both innate and adaptive immune systems.
In order to consider an adult to be physically active, it is generally accepted to reach at
least 150 minutes of moderate or 75 minutes of high-intensity activity per week, or an
equivalent combination of both. Sedentary behavior is defined as wakeful behavior
characterized by an energy expenditure of less than 1.5 metabolic equivalent (MET) in
positions such as lying, sitting or standing. While the COVID-19 disease spreads all over the
world, healthy people are asked to stay at home for a long time against the risk of
transmission. As a result, COVID-19 is radically changing the determinants of both behaviors
(individual, interpersonal, environmental, regional or national policies and global).
Accordingly, it can be said that due to isolation and limitations in regular and joint
activities, it can be said that it poses a significant challenge to fulfill physical activity
recommendations and reduce sedentary behavior during the stay at home, especially in the
first weeks when the chance of finding alternatives to keep the population active even at
home is limited. For this reason, individuals are strongly encouraged to engage in physical
activity in the home environment by public health advocates to prevent the potential harmful
effects of protective lifestyle regulations related to COVID-19 and to prevent the
restrictions from causing physical inactivity.
In the light of all this information, in order to contribute to the literature, the aim of
this study is to determine the serum trace element levels and physical activity levels of
COVID-19 patients immediately before the beginning of COVID-19 treatments and compare with
the results of healthy adults.
