- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04694703
Changing of Trace Element, Homocysteine, Oxidative Stress Parameters and Physical Activity Levels in Covid-19
Changing of Trace Element, Homocysteine, Oxidative Stress Parameters and Physical Activity Levels in Patients Diagnosed With COVID-19 Before and After COVID-19 Treatment
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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İzmir, Krocan, 06580
- Kadirhan Ozdemir
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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Covid-19 group
Patients diagnosed with COVID-19 will be enrolled in this group.
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Routine COVID-19 treatment
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change of the levels of Trace Element at baseline and discharge
Časové okno: At baseline and immediately before the discharge
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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.
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At baseline and immediately before the discharge
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Change of Physical Activity Level at baseline and discharge
Časové okno: At baseline and immediately before the discharge
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International Physical Activity Questionnaire will be used to determine the level of physical activity.
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At baseline and immediately before the discharge
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Change of the levels of Homocystein at baseline and discharge
Časové okno: At baseline and immediately before the discharge
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Homocystein levels will be studied by using Enzyme Chemiluminescence Immunoassay (ECLIA) in Medical Biochemistry Laboratory.
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At baseline and immediately before the discharge
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Change of the levels of Oxidative Stress Parameters at baseline and discharge
Časové okno: At baseline and immediately before the discharge
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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.
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At baseline and immediately before the discharge
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change of the levels of Routine Blood Samples (Hemogram) at baseline and discharge
Časové okno: At baseline and immediately before the discharge
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Hemogram results will be taken from patient files.
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At baseline and immediately before the discharge
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Change of the levels of Routine Blood Samples (vitamin D, Troponin T, D-Dimer, iron and ferritin) at baseline and discharge
Časové okno: At baseline and immediately before the discharge
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Levels of vitamin D, Troponin T, D-Dimer, iron and ferritin will be taken from patient files.
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At baseline and immediately before the discharge
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Change of the levels of Routine Blood Samples (C-reactive protein (CRP) and procalcitonin) at baseline and discharge
Časové okno: At baseline and immediately before the discharge
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Levels of C-reactive protein (CRP) and procalcitonin will be taken from patient files.
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At baseline and immediately before the discharge
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Change of the levels of Routine Blood Samples (uric acid, chlorine, blood urea nitrogen (BUN) creatine, albumin and bilirubin) at baseline and discharge
Časové okno: At baseline and immediately before the discharge
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Levels of uric acid, chlorine, blood urea nitrogen (BUN) creatine, albumin and bilirubin will be taken from patient files.
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At baseline and immediately before the discharge
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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