Protocol summary
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Study aim
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The effect of trehalose on inflammatory markers, stress oxidative, clinical symptoms and mortality in patients with head trauma
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Design
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This is a randomized, double-blind, parallel-group, placebo-controlled clinical trial. Eighty participants were randomly assigned to receive daily trehalose supplementation (n = 40) or placebo (n = 40).
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Settings and conduct
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The present study is a double blind randomized parallel clinical trial. The target population includes people with traumatic brain injury in Al-Zahra Hospital. The samples will be randomly divided into intervention and placebo groups and will be studied for 7 days. Inflammatory markers, oxidative stress, clinical symptoms will be measured before and after the intervention, as well as 28, 60 and 90-day mortality and length of stay in the intensive care unit after the study. To double-blind this research, before starting the study, all the capsules are coded as A and B by someone other than the researcher.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: 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
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Intervention groups
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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)
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Main outcome variables
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Serum CRP levels, erythrocyte sedimentation rate (ESR), NUTRIC score, SOFA score, APACHE II score, superoxide dismutase (SOD), malondialdehyde (MDA), total antioxidant capacity (TAC), 28-day, 60-day and 90-day mortality, ICU length of stay, arterial blood gas (ABG) test.
General information
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Reason for update
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The study start date was mistakenly recorded. This study is prospective and was registered in the IRCT system after obtaining ethical approval and before its implementation.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121216011763N55
Registration date:
2022-11-07, 1401/08/16
Registration timing:
prospective
Last update:
2025-03-24, 1404/01/04
Update count:
1
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Registration date
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2022-11-07, 1401/08/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-05-05, 1404/02/15
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Expected recruitment end date
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2025-08-23, 1404/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of trehalose in patients with head trauma
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-09-12, 1400/06/21
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Ethics committee reference number
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IR.NIMAD.REC.1400.092
Health conditions studied
1
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Description of health condition studied
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Brain damage with or without loss of consciousness for an unspecified period of time
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ICD-10 code
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S06.2
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ICD-10 code description
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Diffuse traumatic brain injury
Primary outcomes
1
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Description
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Serum levels of High sensitive C-reactive protein (hs-CRP)
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Timepoint
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Beginning and end of the study
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Method of measurement
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ELISA method
2
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Description
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Erythrocyte Sedimentation Rate (ESR)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Enzymatic method
3
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Description
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NUTRIC score
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Timepoint
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Beginning and end of the study
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Method of measurement
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By scoring a questionnaire including APACHE II and SOFA
4
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Description
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Superoxide Dismutase (SOD)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Blood sample
5
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Description
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Malondialdehyde (MDA)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Blood sample
6
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Description
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Total antioxidant capacity (TAC)
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Timepoint
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Beginning and end of the study
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Method of measurement
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ELISA method
7
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Description
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28-day, 60-day, and 90-day mortality
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Timepoint
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28-day and 90-day
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Method of measurement
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Use official statistics
8
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Description
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Length of stay in the ICU and duration of hospitalization
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Timepoint
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End of the study
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Method of measurement
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By Using the patient's medical record
9
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Description
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Arterial Blood Gas (ABG) test
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Timepoint
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Beginning and end of the study
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Method of measurement
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Blood Test
10
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Description
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SOFA score
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Timepoint
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At the beginning and end of the intervention (7 days)
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Method of measurement
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By scoring the SOFA questionnaire
11
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Description
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APACHE II Score
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Timepoint
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At the beginning and end of the intervention (7 days)
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Method of measurement
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By scoring the APACHE II questionnaire
12
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Description
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Arterial Blood Gas (ABG) test
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Timepoint
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At the beginning and end of the intervention (7 days)
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Method of measurement
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Blood text
Secondary outcomes
1
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Description
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cell blood count (CBC)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Device analysis using cell counter device (hematology analyzer)
2
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Description
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fasting blood sugar (FBS)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Enzymatic methods
3
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Description
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blood urea nitrogen (BUN)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Biochemical test by enzymatic method
4
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Description
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Creatinine (Cr)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Biochemical test by enzymatic method
5
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Description
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Alanine Transaminase (ALT)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Enzymatic photometric method
6
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Description
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Aspartate Aminotransferase (AST)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Enzymatic photometric method
7
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Description
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Weight
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Timepoint
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Beginning and end of the study
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Method of measurement
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Chumlea I formula
8
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Description
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Height
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Timepoint
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Beginning and end of the study
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Method of measurement
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Ulna length formula
9
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Description
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Mid Arm Circumferences (MAC)
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Timepoint
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Beginning and end of the study
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Method of measurement
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Non-elastic tape meters
Intervention groups
1
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Description
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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)
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Category
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Treatment - Other
2
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Description
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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)
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The collected deidentified for the primary outcome measure only will be shared
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When the data will become available and for how long
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6 months after publication
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To whom data/document is available
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Available for people working in academic institutions
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Under which criteria data/document could be used
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To conduct similar studies
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From where data/document is obtainable
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askari@mui.ac.ir
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What processes are involved for a request to access data/document
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The data will be sent to the person within one Month after receiving the request and reviewing the request.
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Comments
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