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IRCT20210116050044N1 IRCT 2021-03-08 Esfahan University of Medical Sciences Effect of vitamin D in treatment of burn The effect of vitamin D supplementation on inflammation and antioxidant markers in the burned hospitalized patients 2021-01-20 anticipated 60 Complete https://irct.ir/trial/53734 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, for random allocation, we used biased coin the method in individual randomization unit by a coin toss, and each person who was eligible for the study with flipping a coin divided into intervention group if it was headed and control group if it was tails, Blinding description: participants, principle investigators, physicians, nurses who care for participants during the trial, data collectors were unaware of the control and intervention groups. N/A Burn of second degree of trunk, unspecified site. Intervention 1: Intervention group: Vitamin D3 is produced in the form of a tablet with a dose of 2000 international units by Darsa Daru Pharmaceutical Company and is recommended for 8 weeks a day (one) at the same time with fatty foods. Intervention 2: Control group: vitamin D placebo is in the form of a pill with a dose of 2000 international units. To prepare a placebo, paraffin from Zahravi Pharmaceutical Company has been used and a placebo is recommended for 8 weeks a day (one) at the same time with the consumption of fatty foods. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patient documents based on ethics in research
public Fahimeh Beigi
Hezar jrib street
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 f.beigi@mail.mui.ac.ir Esfahan University of Medical Sciences scientific Amir mansoor Alavi
Hezar jerib street
Isfahan Iran (Islamic Republic of) 81746-73461 009831036680048 f.beigi@mail.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) people between the ages of 18-60 patients with secondary degree burns with a burn level between 20%-50% Vitamin D <30 ng/ml lack of supplementation vitamin D during the last three months No history underlying diseases including Kidney, Diabetes, hyperthyroidism and other metabolic diseases No pregnancy and breastfeeding 18 years 60 years Both lack of cooperation participators with project facilitators during this study diagnosis of another chronic disease during this study Each patient can be excluded from the study at any stage if he/she is not satisfied with the study T21.20 Burn of second degree of trunk, unspecified site Treatment - Drugs Treatment - Drugs Intervention group: Vitamin D3 is produced in the form of a tablet with a dose of 2000 international units by Darsa Daru Pharmaceutical Company and is recommended for 8 weeks a day (one) at the same time with fatty foods. Control group: vitamin D placebo is in the form of a pill with a dose of 2000 international units. To prepare a placebo, paraffin from Zahravi Pharmaceutical Company has been used and a placebo is recommended for 8 weeks a day (one) at the same time with the consumption of fatty foods. The amount of vitamin D through ELISA test is measured in ng/l. Timepoint: Measurement of vitamin D will be at the beginning of the study (before the intervention) and after the intervention. Method of measurement: The measure of variable is done by ELISA method. Inflammatory factor CRP is measured by photometric enriched turbidolatex method. Timepoint: The variable is measured at the beginning of the study (before the intervention) and after the intervention at the end of the study. Method of measurement: The measurement is done based on the CRP vial. Antioxidant factors are measured in terms of ng / L based on ELISA method. Timepoint: The variable is measured at the beginning of the study (before the intervention) and after the intervention at the end of the study. Method of measurement: The method of measuring antioxidant factors by ELISA kit. Esfahan University of Medical Sciences Approved 2020-11-11 Ethics Committee of Isfahan University of Medical Sciences hezar jerib street Isfahan Isfehan Iran (Islamic Republic of)