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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20121216011763N55

Enrollment

Registered

2022-11-07

Start date

2025-05-05

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain damage with or without loss of consciousness for an unspecified period of time. Diffuse traumatic brain injury

Interventions

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).

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactGholamreza Askari

Esfahan University of Medical Sciences

askari@mui.ac.ir+98 31 3792 3171

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026