The effects of zinc supplementation in patients with sepsis: a clinical trial

Determining the additive effects of zinc supplementation compared to placebo in sepsis patients in the intensive care unit

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 56 patients.

The study is a randomized controlled clinical trial intervention on patients with sepsis who are admitted to the special care units of Shariati Hospital for 7 days, with zinc supplement and control with placebo.

criteria of inclusion: 1. Age over 18 years 2. A patient admitted to the intensive care unit 3. A patient with sepsis 4. Patients under enteral nutrition (nasal, mouth, stomach) criteria of exclusion: 1. Pregnancy or breastfeeding 2. Body mass index over 35 (severe obesity) 3. Acquired immunodeficiency virus (HIV) disease 4. Patients at the time of transplantation 5. Patients with orders not to receive any type of enteral nutrition 6. Patients participating in other studies

Patients in the intervention group will be given a zinc supplement containing 30 mg of elemental zinc. In the control group, the placebo will be similar in terms of shape and composition, with the only difference in the absence of the element. During the 7 daysو patients will receive 1 zinc supplement tablet in the intervention group and placebo in the control group.

mNUTRIC, SOFA questionnaire score

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.

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.