Changing of Trace Element, Homocysteine, Oxidative Stress Parameters and Physical Activity Levels in Covid-19

NCT04694703 | Completed

• 1 other identifier: 2020-12-142
• Study Type: observational
• Target: 15
• 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, researches on many different drug approaches have begun and these researches continue today. Considering the absence of a specific treatment for the disease yet and the urgency of the situation, drugs previously licensed for the treatment of other diseases and thought to be effective in COVID-19 have started to be used. Ongoing studies are conducted on the effectiveness, possible side effects and safety of these drugs in COVID-19, but there is no clear information yet. 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 homocysteine and oxidative stress, which can provide information on determining the risk of cardiovascular complications in the COVID-19 pandemic. In addition, as the decrease in physical activity levels of individuals in the COVID-19 pandemic may cause possible secondary complications such as an increase in the risk of cardiovascular disease, determining the physical activity levels of individuals and encouraging them to physical activity is another important parameter to minimize the negative effects of the process. It is thought that investigating the effects of the treatment approaches used in COVID-19 on trace element, homocysteine, oxidative stress parameters and physical activity levels will provide useful information in determining the factors underlying better clinical results. This study was planned to be carried out between 6-31 January 2021 in order to compare the trace element, homocysteine, oxidative stress parameters and physical activity levels before and after treatment for COVID-19 disease in COVID-19 patients who applied to Izmir Bakircay University Cigli Training and Research Hospital (Cigli Regional Training Hospital) and hospitalized in the COVID-19 service. 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); Trace element; Homocystein; Oxidative stress parameters; Physical activity level

Outcome Measures

Primary Outcomes (4)

• Change of the levels of Trace Element at baseline and discharge

  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 and immediately before the discharge

• Change of Physical Activity Level at baseline and discharge

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

  At baseline and immediately before the discharge

• Change of the levels of Homocystein at baseline and discharge

  Homocystein levels will be studied by using Enzyme Chemiluminescence Immunoassay (ECLIA) in Medical Biochemistry Laboratory.

  At baseline and immediately before the discharge

• Change of the levels of Oxidative Stress Parameters at baseline and discharge

  Oxidative Stress Parameters including Superoxide Dismutase (SOD), Malondialdehyde (MDA), Total Antioxidant Level (TAL) / Total Oxidant Level (TOL) will be studied by photometric method in Medical Biochemistry Laboratory.

  At baseline and immediately before the discharge

Secondary Outcomes (4)

• Change of the levels of Routine Blood Samples (Hemogram) at baseline and discharge

  At baseline and immediately before the discharge

• Change of the levels of Routine Blood Samples (vitamin D, Troponin T, D-Dimer, iron and ferritin) at baseline and discharge

  At baseline and immediately before the discharge

• Change of the levels of Routine Blood Samples (C-reactive protein (CRP) and procalcitonin) at baseline and discharge

  At baseline and immediately before the discharge

• Change of the levels of Routine Blood Samples (uric acid, chlorine, blood urea nitrogen (BUN) creatine, albumin and bilirubin) at baseline and discharge

  At baseline and immediately before the discharge

Study Arms (1)

Covid-19 group

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

Drug: Covid-19 group

Interventions

Covid-19 group DRUG

Routine COVID-19 treatment

Covid-19 group

Eligibility Criteria

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

Study Population

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

You may qualify if:

• To agree to participate in the study voluntarily,
• Having a diagnosis of COVID-19,

You may not qualify if:

• Having been taking trace element supplements for the last 2 weeks and/or currently,
• Patients who do not need hospitalization,
• Having a diagnosis of kidney failure and/or heart failure,
• Being pregnant,
• Body mass index over 40 kg/m2

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

Related Links

• Adult Patient Treatment Guide for COVID-19 (Ministry of Health, Republic of Turkey)

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: 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: July 15, 2021
• Study Completion: August 29, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)