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IRCT20220208053971N3 IRCT 2023-06-10 Tehran University of Medical Sciences Investigating the effects of zinc supplementation in patients with blood infection The effects of zinc supplementation in patients with sepsis: a clinical trial 2023-07-21 anticipated 56 Complete https://irct.ir/trial/70041 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done by stratified permute block randomization method in two strata based on (age and sex) using the website www.sealedenvelope.com. In this method, randomization will be done based on 28 blocks of 2, which is suitable for a sample size of 56 people with two intervention and control groups. Within each class, patients will be randomly assigned to one of the two study groups in a ratio of 1:1, Blinding description: All subjects and their companions and researchers and healthcare personnel who are responsible for the care of patients will be unaware of the existing grouping until the end of the study; In such a way, the researcher and the person who takes the sample, like the study participants, are unaware of which patients are receiving zinc supplements or placebo. Patients and their companions are also unaware of the type of pill received. Drugs and placebos are coded by a person who is completely unaware of the study process, and this code is placed in an envelope that indicates whether it is a drug or a placebo code. One group will receive drug A and one group will receive drug B. Also, pills containing zinc supplements and placebo, which have the same color, smell, and size with the same shape, will be used. Hence, this study will be a double-blind study. Placebo tablets contain starch and are completely similar to zinc supplement tablets in terms of color, appearance and smell. Placebo tablets are also prepared by the same company that manufactures the placebo. 2 sepsis. Intervention 1: Intervention group: The patients in the intervention group will be given a zinc supplement containing 30 mg of Karen Zinc for 7 days. Intervention 2: Control group: In the control group, the placebo will be similar in terms of shape and composition, with the only difference from the intervention group in the absence of the element. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hamed Mohammadi
No: 44 Hojjat-dost Alley, Naderi St
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8895 5975 info_snsd@tums.ac.ir Tehran University of Medical Sciences scientific Hamed Mohammadi
No: 44 Hojjat-dost Alley, Naderi St
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8895 5975 info_snsd@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years patient admitted to the intensive care unit patient with sepsis Patients under enteral nutrition (nasal, mouth, stomach) 18 years no limit Both Pregnancy or breastfeeding Body mass index over 35 (severe obesity) Human immunodeficiency virus (HIV) disease Patients at the time of transplantation Patients with orders not to receive any type of enteral nutrition Patients participating in other studies A41.9 Sepsis, unspecified organism Other Placebo Intervention group: The patients in the intervention group will be given a zinc supplement containing 30 mg of Karen Zinc for 7 days. Control group: In the control group, the placebo will be similar in terms of shape and composition, with the only difference from the intervention group in the absence of the element. Sequential Organ Failure Assessment. Timepoint: The effect of zinc supplementation on the SOFA score at the beginning of the study (before the intervention) and 1 week after the intervention in patients with sepsis in the intensive care unit. Method of measurement: SOFA questionnaire score. 28-day mortality. Timepoint: The effect of zinc supplementation on the 28-day mortality at the beginning of the study (before the intervention) and 1 week after the intervention in patients with sepsis in the intensive care unit. Method of measurement: questionnaire. Inflammatory factors. Timepoint: The effect of zinc supplementation on the Inflammatory factors at the beginning of the study (before the intervention) and 1 week after the intervention in patients with sepsis in the intensive care unit. Method of measurement: blood test. Nutritional status. Timepoint: The effect of zinc supplementation on the nutritional status at the beginning of the study (before the intervention) and 1 week after the intervention in patients with sepsis in the intensive care unit. Method of measurement: mNUTRIC questionnaire score. Tehran University of Medical Sciences Approved 2023-05-07 Shariati Hospital - Tehran University of Medical Sciences (Research Ethics Committee) Karegar Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)