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IRCT20121216011763N55 IRCT 2022-11-07 Esfahan University of Medical Sciences Effect of trehalose in patients with head trauma The effect of trehalose on inflammatory markers, stress oxidative, clinical symptoms and mortality in patients with head trauma: a randomized double-blind placebo controlled trial 2025-05-05 anticipated 80 Complete https://irct.ir/trial/66521 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants will be randomly allocated in a ratio of 1:1 to either the intervention group or the control group. Randomization will be stratified according to sex (male vs. female), with the use of permuted block size of 4. group. For randomization the below website will be used: https://www.sealedenvelope.com/simple -randomiser/ v1/lists, Blinding description: To run this study as a double -blinded study, before intervention, all sachets are encoded by a trained nutritionist, researchers will not be informed about randomization process until completion of data analyses (concealment). Trehalose and its placebos will in the same form of package in terms of the size, color, shape, and the patients and researcher will not aware of the content of the pack until the end of trial. 3 Brain damage with or without loss of consciousness for an unspecified period of time. Intervention 1: Intervention group: Intervention group will be fed by standard formula and two daily sachets (each sachets contains 5 grams trehalose; totally 10 gram trehalose in a day). Intervention 2: Control group: control group will feed with standard formula and two sachets filledwith maltodextrin (each sachets contains 5 grams maltodextrin; totally 10 grams maltodextrin in a day). Yes - There is a plan to make this available What will be shared: The collected deidentified for the primary outcome measure only will be shared When: 6 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: askari@mui.ac.ir How to obtain: The data will be sent to the person within one Month after receiving the request and reviewing the request. Comments:
public Gholamreza Askari
Department of Community Nutrition, Faculty of Nutrition, Isfahan University of Medical Sciences, Hezar Jerib St
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3171 askari@mui.ac.ir Esfahan University of Medical Sciences scientific Gholamreza Askari
Department of Community Nutrition, Faculty of Nutrition, Isfahan University of Medical Sciences, Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3171 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 18-65 years Diagnosis of head trauma by a physician and trauma diagnosis based on Injury Severity Score (ISS)between minor to severe Willingness to participation in the study and complete the informed consent form Gastrointestinal tract with normal function and intestinal nutritional criteria 18 years 65 years Both Using parenteral nutrition People who do not tolerate enteral nutrition well and for any reason are supported by completeintravenous nutrition. Infection processes, diffuse intravascular coagulation and any inflammatory interactions that interfere with the intervention process. Unexpected adverse effects S06.2 Diffuse traumatic brain injury Treatment - Other Placebo Intervention group: Intervention group will be fed by standard formula and two daily sachets (each sachets contains 5 grams trehalose; totally 10 gram trehalose in a day) Control group: control group will feed with standard formula and two sachets filledwith maltodextrin (each sachets contains 5 grams maltodextrin; totally 10 grams maltodextrin in a day) Serum levels of High sensitive C-reactive protein (hs-CRP). Timepoint: Beginning and end of the study. Method of measurement: ELISA method. Erythrocyte Sedimentation Rate (ESR). Timepoint: Beginning and end of the study. Method of measurement: Enzymatic method. NUTRIC score. Timepoint: Beginning and end of the study. Method of measurement: By scoring a questionnaire including APACHE II and SOFA. Superoxide Dismutase (SOD). Timepoint: Beginning and end of the study. Method of measurement: Blood sample. Malondialdehyde (MDA). Timepoint: Beginning and end of the study. Method of measurement: Blood sample. Total antioxidant capacity (TAC). Timepoint: Beginning and end of the study. Method of measurement: ELISA method. 28-day, 60-day, and 90-day mortality. Timepoint: 28-day and 90-day. Method of measurement: Use official statistics. Length of stay in the ICU and duration of hospitalization. Timepoint: End of the study. Method of measurement: By Using the patient's medical record. Arterial Blood Gas (ABG) test. Timepoint: Beginning and end of the study. Method of measurement: Blood Test. SOFA score. Timepoint: At the beginning and end of the intervention (7 days). Method of measurement: By scoring the SOFA questionnaire. APACHE II Score. Timepoint: At the beginning and end of the intervention (7 days). Method of measurement: By scoring the APACHE II questionnaire. Arterial Blood Gas (ABG) test. Timepoint: At the beginning and end of the intervention (7 days). Method of measurement: Blood text. Cell blood count (CBC). Timepoint: Beginning and end of the study. Method of measurement: Device analysis using cell counter device (hematology analyzer). Fasting blood sugar (FBS). Timepoint: Beginning and end of the study. Method of measurement: Enzymatic methods. Blood urea nitrogen (BUN). Timepoint: Beginning and end of the study. Method of measurement: Biochemical test by enzymatic method. Creatinine (Cr). Timepoint: Beginning and end of the study. Method of measurement: Biochemical test by enzymatic method. Alanine Transaminase (ALT). Timepoint: Beginning and end of the study. Method of measurement: Enzymatic photometric method. Aspartate Aminotransferase (AST). Timepoint: Beginning and end of the study. Method of measurement: Enzymatic photometric method. Weight. Timepoint: Beginning and end of the study. Method of measurement: Chumlea I formula. Height. Timepoint: Beginning and end of the study. Method of measurement: Ulna length formula. Mid Arm Circumferences (MAC). Timepoint: Beginning and end of the study. Method of measurement: Non-elastic tape meters. Esfahan University of Medical Sciences Approved 2021-09-12 National Institute for Medical Research Development (NIMAD) Besat street Tehran Tehran Iran (Islamic Republic of)