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IRCT20200115046141N1 IRCT 2020-03-10 Ahvaz University of Medical Sciences trace element supplementation in burned patients Comparison of the effects of regular dose and elevated dose of trace element supplementation on nutritional status and general condition of burned injured patients admitted to BICU 2020-05-04 anticipated 48 Complete https://irct.ir/trial/46154 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block Randomization with computer software, Blinding description: Participants (patients) will not be informed that they are in the control or intervention group. N/A burn. Intervention 1: Intervention group: on the first ,third and fifth day of hospitalization patients will receive two doses of Addamel in the form of injection supplement.(three times and each time two doses) each dose contains:1.1 milligrams Iron,6.5 milligrams Zinc , 1.3 milligrams Copper, 0.27 milligrams Manganese, 0.13 milligrams Iodine , 32 micrograms Selenium , 10 micrograms Chromium , 19 micrograms Molybdenum, and 0.95 milligrams Fluorine. Intervention 2: Control group: on the first ,third and fifth day of hospitalization patients will receive one dose of Addamel in the form of injection supplement.(three times and each time one dose) each dose contains:1.1 milligrams Iron,6.5 milligrams Zinc , 1.3 milligrams Copper, 0.27 milligrams Manganese, 0.13 milligrams Iodine , 32 micrograms Selenium , 10 micrograms Chromium , 19 micrograms Molybdenum, and 0.95 milligrams Fluorine. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the financial support of this research project by Ahvaz Jundishapur University of Medical Science ,the study data will not be allowed to be published after the intervention.
public Pegah Sajadi
No. 19, East 23 Ave, Kian Abad
Ahvaz Iran (Islamic Republic of) 6155764566 +98 61 3337 1272 sajadi.p@ajums.ac.ir Ahvaz University of Medical Sciences scientific Durdana Husain
Nutrition Department, Ahvaz Jundishapur University of Medical Science, Golestan highway
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8383 husain-d@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Staying in ICU for more than 72 hours Burn percentage: between 20 and 60 18 years no limit Both Patients with liver disorders Patients with Nephrotic Syndrome Hemodynamic instability Increased lactate in serum Pregnancy T30-2, T30 Burn of second degree, body region unspecified, Burn of third degree, body region unspecified Prevention Prevention Intervention group: on the first ,third and fifth day of hospitalization patients will receive two doses of Addamel in the form of injection supplement.(three times and each time two doses) each dose contains:1.1 milligrams Iron,6.5 milligrams Zinc , 1.3 milligrams Copper, 0.27 milligrams Manganese, 0.13 milligrams Iodine , 32 micrograms Selenium , 10 micrograms Chromium , 19 micrograms Molybdenum, and 0.95 milligrams Fluorine Control group: on the first ,third and fifth day of hospitalization patients will receive one dose of Addamel in the form of injection supplement.(three times and each time one dose) each dose contains:1.1 milligrams Iron,6.5 milligrams Zinc , 1.3 milligrams Copper, 0.27 milligrams Manganese, 0.13 milligrams Iodine , 32 micrograms Selenium , 10 micrograms Chromium , 19 micrograms Molybdenum, and 0.95 milligrams Fluorine Hospitalization days. Timepoint: at the end of the study. Method of measurement: based on the number of the days. Ventilation time. Timepoint: at the end of the study. Method of measurement: based on the number of the days. Hospital-acquired infection rate. Timepoint: first , third and fifth day of hospitalization. Method of measurement: white blood cell count. Changes in patients' nutritional status. Timepoint: first , third and fifth day of hospitalization. Method of measurement: measuring blood indexes like albumin , creatinine, sodium and potassium. Ahvaz University of Medical Sciences Approved 2020-02-24 Ethics committee of Jundishapur university of Medical Sciences No .19. East 23 street. Kian abad Ahvaz Khouzestan Iran (Islamic Republic of)