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

14 settembre 2021 aggiornato da: Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University

Changing of Trace Element, Homocysteine, Oxidative Stress Parameters and Physical Activity Levels in Patients Diagnosed With COVID-19 Before and After COVID-19 Treatment

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Since December 2019, the new severe acute respiratory syndrome coronavirus 2, called SARS-CoV-2, has spread rapidly to almost every country that causes coronavirus disease-19 (COVID-19) pneumonia. Currently, there is no specific treatment for COVID-19 with proven safety and effectiveness. In order to find an effective treatment for this disease, more than 100 randomized controlled trials are currently being conducted with many drugs, some of them are expected to be announced in the coming months. It is known that the use of treatment options within the framework of randomized controlled studies and based on information obtained from other scientific studies is more rational. However, due to the urgency of the current situation and the limited scientific data, treatment options with limited data on their effectiveness are widely used for these patients all over the world. As in general of viral infections, the data obtained from SARS and influenza suggest that early initiation of antiviral treatment is more beneficial, and antiviral drugs should be started as early as possible. The combined use of possible treatment options in COVID-19 patients should be considered on a patient-specific basis and by evaluating all the relevant literature, and attention should be paid to the interactions and adverse effects of the drugs used.

Since it will take a long time to find a treatment specific to COVID-19, during the current pandemic, drugs such as hydroxychloroquine, favipiravir, remdesivir, lopinavir-ritonavir, which have been previously licensed for the treatment of other diseases in humans, have been widely used in these indications, have been shown to be safe and are effective in SARS CoV-2 in vitro, have been recommended and used. Numerous studies are still ongoing on the efficacy and safety of these drugs in COVID-19.

The clinical picture of COVID-19 can be heterogeneous, ranging from asymptomatic to severe disease, which can be associated with a cytokine storm. The pathogenesis of COVID-19 is not fully understood, but is likely multifactorial and, in severe cases, with a systemic hyperinflammatory response and associated thromboembolic complications.

It may be beneficial for patients infected with COVID-19 due to the anti-inflammatory and antioxidant properties of certain vitamins and nutrients. Vitamins such as A, B, C, D, E and folate and trace elements such as iron, zinc, magnesium, selenium and copper play important roles in supporting both innate and adaptive immune systems.

High plasma homocysteine levels significantly increase the incidence of vascular damage in both small and large vessels. Concentrations above the 90th percentile are associated with an increased risk of degenerative and atherosclerotic processes in the coronary, cerebral and peripheral circulatory systems. Although homocysteine is an effective cardiovascular risk biomarker and is critical for cardiovascular complications in hospitalized COVID-19 patients, studies on this parameter have not focused much on laboratory markers useful for clinical evaluation of COVID-19.

Free radicals are continuously formed at the active site of enzymes as intermediates in enzymatic reactions occurring during cell metabolism. Reactive oxygen species and reactive nitrogen, known as intermediates, sometimes leach from the active site of enzymes and accidentally interact with molecular oxygen and form free oxygen radicals. Lipids, proteins, enzymes, carbohydrates, and DNA can be damaged due to oxidative stress, random breaks and bonds in DNA chains may occur as a result of damage to membranes, damage to enzymes and structural proteins may result in cell death, and these phenomena constitute the molecular basis in the development of cancer, neurodegenerative and cardiovascular diseases, diabetes and autoimmune disorders.

The general recommendation for thinking that an adult is physically active is to achieve at least 150 minutes of moderate or 75 minutes of vigorous vigorous activity per week, or an equivalent combination of both, and involving sedentary behavior, energy expenditure ≤ 1.5 metabolic equivalent (MET), while lying down, leaning, It is defined as any waking behavior practiced while sitting or standing. As the disease spreads all over the world, healthy people are asked to stay at home for a long time. As a result, COVID-19 has radically changed the determinants of both behaviors (individual, interpersonal, environmental, regional or national policies and global). Accordingly, it can be said that regular and joint activities decrease due to isolation and limitations, especially in the first weeks when the population has limited chances to find alternatives to keep active even at home, and reducing sedentary behavior during closure poses a significant challenge. Because of this situation, physical activity in the home environment is strongly encouraged by public health advocates to prevent the potential harmful effects of protective lifestyle regulations due to COVID-19 and to prevent the restrictions from causing physical inactivity.

The purpose of this study is to compare the trace element, homocysteine, oxidative stress parameters and physical activity levels before and after COVID-19 treatment according to the COVID-19 treatment guide published by Ministry of Health, Republic of Turkey.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

15

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • İzmir, Tacchino, 06580
        • Kadirhan Ozdemir

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 35 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

N/A

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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).

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Covid-19 group
Patients diagnosed with COVID-19 will be enrolled in this group.
Routine COVID-19 treatment

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of the levels of Trace Element at baseline and discharge
Lasso di tempo: At baseline and immediately before the 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
Lasso di tempo: At baseline and immediately before the 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
Lasso di tempo: At baseline and immediately before the 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
Lasso di tempo: At baseline and immediately before the 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of the levels of Routine Blood Samples (Hemogram) at baseline and discharge
Lasso di tempo: At baseline and immediately before the discharge
Hemogram results will be taken from patient files.
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
Lasso di tempo: At baseline and immediately before the discharge
Levels of vitamin D, Troponin T, D-Dimer, iron and ferritin will be taken from patient files.
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
Lasso di tempo: At baseline and immediately before the discharge
Levels of C-reactive protein (CRP) and procalcitonin will be taken from patient files.
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
Lasso di tempo: At baseline and immediately before the discharge
Levels of uric acid, chlorine, blood urea nitrogen (BUN) creatine, albumin and bilirubin will be taken from patient files.
At baseline and immediately before the discharge

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 gennaio 2021

Completamento primario (Effettivo)

15 luglio 2021

Completamento dello studio (Effettivo)

29 agosto 2021

Date di iscrizione allo studio

Primo inviato

3 gennaio 2021

Primo inviato che soddisfa i criteri di controllo qualità

3 gennaio 2021

Primo Inserito (Effettivo)

5 gennaio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 settembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 settembre 2021

Ultimo verificato

1 settembre 2021

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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