Determination of Serum Trace Element and Physical Activity Levels in COVID-19

NCT04694716 | Completed

• 1 other identifier: 2020-12-141
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Keywords

Covid-19 (SARS-CoV-2); Serum trace elements; Physical activity

Outcome Measures

Primary Outcomes (2)

• Levels of serum trace elements parameters

  Serum trace elements (zinc, selenium, potassium, sodium, calcium, magnesium, 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.

  At baseline

• Physical Activity Level

  International Physical Activity Questionnaire will be used to determine the level of physical activity.

  At baseline

Secondary Outcomes (1)

• Levels of Routine Blood Samples

  At baseline

Study Arms (2)

Covid-19 group (Group I)

Patients diagnosed with Covid-19 will be enrolled in this group.

Other: No intervention

Control group (Group II)

Healthy individuals will be enrolled in this group.

Other: No intervention

Interventions

No intervention OTHER

No intervention will be applied.

Control group (Group II); Covid-19 group (Group I)

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants in Group I will be included the study from Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital). Participants in Group II will be included the study from community sample.

You may qualify if:

• Having a diagnosis of COVID-19 for Group I,
• Not having any chronic diseases for Group II,

You may not qualify if:

• Having been taking trace element supplements for the last 2 weeks
• Patients who do not require hospitalization for Group I,
• Patients with a diagnosis of kidney failure and/or heart failure for Group I,
• Patients who are pregnant for Group I

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; Motor Activity

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; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 5, 2021
• Study Start: January 6, 2021
• Primary Completion: May 15, 2021
• Study Completion: August 15, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)