The Effects of High-dose Selenium Supplementation on the Oxidative Stress Status and Inflammatory Markers in Critically Ill Pediatric Patients after Gastrointestinal Surgery: A Randomized Clinical Trial Protocol Study

<strong>Introduction: </strong>Oxidative stress and inflammation could occur after major gastrointestinal surgeries. Selenium is a micronutrient with anti-inflammatory and antioxidant properties, which could improve the inflammatory markers in the children admitted to the intensive care...

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Main Authors: Fatemeh Roudi, Majid Sezavar, Omid Rajabi, Mohammad Safarian, Gholamreza Khademi, Mohsen Nematy, Golnaz Ranjbar
Format: Article
Language:English
Published: Mashhad University of Medical Sciences 2020-09-01
Series:Journal of Fasting and Health
Subjects:
Online Access:http://jnfh.mums.ac.ir/article_15530_8ae7f31eaa8fb332c70e532dd0493323.pdf
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author Fatemeh Roudi
Majid Sezavar
Omid Rajabi
Mohammad Safarian
Gholamreza Khademi
Mohsen Nematy
Golnaz Ranjbar
author_facet Fatemeh Roudi
Majid Sezavar
Omid Rajabi
Mohammad Safarian
Gholamreza Khademi
Mohsen Nematy
Golnaz Ranjbar
author_sort Fatemeh Roudi
collection DOAJ
description <strong>Introduction: </strong>Oxidative stress and inflammation could occur after major gastrointestinal surgeries. Selenium is a micronutrient with anti-inflammatory and antioxidant properties, which could improve the inflammatory markers in the children admitted to the intensive care unit (ICU) after gastrointestinal surgeries. Due to the lack of evidence on the potential effects of high-dose selenium on post-surgical critically ill children, the present study aimed to evaluate the effects of high-dose selenium supplementation on the levels of inflammatory markers and oxidative stress status in pediatric patients after gastrointestinal surgery. <strong>Methods and analysis:</strong> We will conduct a single-blinded, randomized, parallel group superiority trial at Akbar Pediatrics Hospital in Mashhad, Iran. The sample population will consist of 70 patients undergoing gastrointestinal surgery, who will admit to the ICU at the selected hospital. The control group will receive the recommended dietary allowance (RDA) doses of selenium, and the intervention group will receive 20 µg/kg/d of selenium. The primary outcomes, (the pro-oxidant-antioxidant balance (PAB) status, interleukin-1 beta (IL-1β), and high-sensitivity C-reactive protein (hs-CRP)) will be measured before surgery and upon discharge time. The secondary outcomes, (serum glutathione peroxidase (GPX) level and serum and urine selenium levels), will be measured before surgery, after surgery, and upon ICU discharge time. We will perform the intra-group and inter-group data analysis in SPSS software, and we will consider the intention-to-treat approach, statistical significance level of <0.05, and 95% confidence interval in all the statistical analyses. <strong><br /></strong>
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spelling doaj.art-92c9b5d4705944df9aebae50403e8de22022-12-21T21:03:39ZengMashhad University of Medical SciencesJournal of Fasting and Health2345-25872345-25872020-09-018315916810.22038/jnfh.2020.48170.126115530The Effects of High-dose Selenium Supplementation on the Oxidative Stress Status and Inflammatory Markers in Critically Ill Pediatric Patients after Gastrointestinal Surgery: A Randomized Clinical Trial Protocol StudyFatemeh Roudi0Majid Sezavar1Omid Rajabi2Mohammad Safarian3Gholamreza Khademi4Mohsen Nematy5Golnaz Ranjbar6Department of Nutrition, Mashhad University of Medical Sciences, Mashhad, IranDepartment of Pediatrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, IranDepartment of Drug Control, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, IranDepartment of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, IranNeonatal Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, IranDepartment of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, IranPhD in Nutritional Sciences, Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran<strong>Introduction: </strong>Oxidative stress and inflammation could occur after major gastrointestinal surgeries. Selenium is a micronutrient with anti-inflammatory and antioxidant properties, which could improve the inflammatory markers in the children admitted to the intensive care unit (ICU) after gastrointestinal surgeries. Due to the lack of evidence on the potential effects of high-dose selenium on post-surgical critically ill children, the present study aimed to evaluate the effects of high-dose selenium supplementation on the levels of inflammatory markers and oxidative stress status in pediatric patients after gastrointestinal surgery. <strong>Methods and analysis:</strong> We will conduct a single-blinded, randomized, parallel group superiority trial at Akbar Pediatrics Hospital in Mashhad, Iran. The sample population will consist of 70 patients undergoing gastrointestinal surgery, who will admit to the ICU at the selected hospital. The control group will receive the recommended dietary allowance (RDA) doses of selenium, and the intervention group will receive 20 µg/kg/d of selenium. The primary outcomes, (the pro-oxidant-antioxidant balance (PAB) status, interleukin-1 beta (IL-1β), and high-sensitivity C-reactive protein (hs-CRP)) will be measured before surgery and upon discharge time. The secondary outcomes, (serum glutathione peroxidase (GPX) level and serum and urine selenium levels), will be measured before surgery, after surgery, and upon ICU discharge time. We will perform the intra-group and inter-group data analysis in SPSS software, and we will consider the intention-to-treat approach, statistical significance level of <0.05, and 95% confidence interval in all the statistical analyses. <strong><br /></strong>http://jnfh.mums.ac.ir/article_15530_8ae7f31eaa8fb332c70e532dd0493323.pdfseleniuminflammationoxidative stressintensive care unit, pediatric
spellingShingle Fatemeh Roudi
Majid Sezavar
Omid Rajabi
Mohammad Safarian
Gholamreza Khademi
Mohsen Nematy
Golnaz Ranjbar
The Effects of High-dose Selenium Supplementation on the Oxidative Stress Status and Inflammatory Markers in Critically Ill Pediatric Patients after Gastrointestinal Surgery: A Randomized Clinical Trial Protocol Study
Journal of Fasting and Health
selenium
inflammation
oxidative stress
intensive care unit, pediatric
title The Effects of High-dose Selenium Supplementation on the Oxidative Stress Status and Inflammatory Markers in Critically Ill Pediatric Patients after Gastrointestinal Surgery: A Randomized Clinical Trial Protocol Study
title_full The Effects of High-dose Selenium Supplementation on the Oxidative Stress Status and Inflammatory Markers in Critically Ill Pediatric Patients after Gastrointestinal Surgery: A Randomized Clinical Trial Protocol Study
title_fullStr The Effects of High-dose Selenium Supplementation on the Oxidative Stress Status and Inflammatory Markers in Critically Ill Pediatric Patients after Gastrointestinal Surgery: A Randomized Clinical Trial Protocol Study
title_full_unstemmed The Effects of High-dose Selenium Supplementation on the Oxidative Stress Status and Inflammatory Markers in Critically Ill Pediatric Patients after Gastrointestinal Surgery: A Randomized Clinical Trial Protocol Study
title_short The Effects of High-dose Selenium Supplementation on the Oxidative Stress Status and Inflammatory Markers in Critically Ill Pediatric Patients after Gastrointestinal Surgery: A Randomized Clinical Trial Protocol Study
title_sort effects of high dose selenium supplementation on the oxidative stress status and inflammatory markers in critically ill pediatric patients after gastrointestinal surgery a randomized clinical trial protocol study
topic selenium
inflammation
oxidative stress
intensive care unit, pediatric
url http://jnfh.mums.ac.ir/article_15530_8ae7f31eaa8fb332c70e532dd0493323.pdf
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