Protocol summary
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Study aim
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The main aim of the study is to investigate the effect of trehalose on inflammation and wound healing in humans.
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Design
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This randomized, double-blind clinical trial will be conducted with a parallel control group. The sample size was determined using G*Power software. Randomization will be performed using the Permuted Block Randomization method.
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Settings and conduct
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This clinical trial will be conducted at Taleghani Hospital in Tehran. Patients, researchers, and all medical personnel, except for one administering nurse, will be blinded to the type of intervention prescribed for the patient.
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Participants/Inclusion and exclusion criteria
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A diagnosis of peri-trochanteric fractures is the inclusion criterion for the study. Various chronic diseases, infections, and immunodeficiency are exclusion criteria.
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Intervention groups
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The intervention group will receive 3.3 grams of trehalose daily, and the control group will receive 3.3 grams of placebo (containing sucrose) daily for 12 weeks. Demographic questionnaire completion, wound assessment based on the Wound Healing Index (WHI), patient dietary intake (PDI), and inflammatory factors (IL-6, ESR, CRP, TNF-a) will be measured before the intervention. The Wound Healing Index (WHI) will be completed at discharge and at weeks 2 and 4. Inflammatory factors (IL-6, ESR, CRP, TNF-a) will be completed in weeks 4 and 12. At the end of 12 weeks: Dietary intake questionnaire (PDI), Body Mass Index (BMI), and measurement of inflammatory factors (IL-6, ESR, CRP, TNF-a) will be conducted.
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Main outcome variables
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Comparison of changes in wound healing and inflammation within each group and between the two groups.
General information
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Reason for update
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The exclusion criteria section was completed with higher accuracy
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180404039188N5
Registration date:
2024-07-07, 1403/04/17
Registration timing:
prospective
Last update:
2024-10-02, 1403/07/11
Update count:
2
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Registration date
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2024-07-07, 1403/04/17
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2024-12-21, 1403/10/01
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Expected recruitment end date
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2025-12-22, 1404/10/01
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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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Determining the Effects of Trehalose Consumption on Inflammation and Wound Healing in Patients with Peri-Trochanteric Fractures
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Public title
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Effects of Trehalose on Peri-Trochanteric Fractures
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Admission to the orthopedic department of Talaghani Hospital with a diagnosis of pertrochanteric fractures.
Age between 18 and 60 years.
Injury Severity Score (ISS) less than 15.
Willingness to cooperate and sign an informed consent form after full awareness of the study objectives and methods by the patient or their legal guardian.
Exclusion criteria:
Pregnancy and lactation.
Septic patients with unstable hemodynamics and metabolism.
History of autoimmune diseases or disorders.
History of cancer.
Chemotherapy and radiotherapy within the past month.
Diabetes mellitus
Any type of liver failure
Human immunodeficiency virus (HIV) infection.
Morbid obesity (BMI > 40)
Unwillingness to participate in the study
Significant change in the patient's treatment process or admission to the ICU
Intolerance to trehalose
Patient being NPO and unable to start oral feeding
Development of infection during the recovery and improvement period
Alcohol consumption
Smoking
Different and heavy physical activity programs
Those who are on a specific diet throughout the study
Weight changes (±3) during the study
Have a history of taking antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs) during the last month
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Age
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From 18 years old to 60 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:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization in this study will be conducted using the Premuted Block Randomization method. Patients will be randomly assigned to the intervention or placebo group. Randomization was obtained by a computer-based random number generator (https://www.randomizer.org). For random allocation, these conditions will be provided to the respective nurse. It is worth mentioning that patients, researchers, and all medical personnel except for one administering nurse will be blinded to the type of intervention prescribed for the patient (trehalose or placebo). Participation was voluntary, and the participants could quit the study any time they wanted. The confidentiality of the sample and the data of participants were guaranteed. The study protocol was registered at the Ethics Committee of Shahid Beheshti University of Medical Sciences.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Both participants and data analyzers will be blinded in this study. The trehalose supplement and placebo should have exactly the same color, smell, and packaging in order to provide appropriate blinding. The intervention and control groups will remain unknown to the analyst. Unblinding will take place in the event of unique clinical situations and potentially fatal side effects.
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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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2024-06-18, 1403/03/29
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Ethics committee reference number
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IR.SBMU.MSP.REC.1403.191
Health conditions studied
1
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Description of health condition studied
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Peri-trochanteric fractures
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ICD-10 code
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S72.1
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ICD-10 code description
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Pertrochanteric fracture
Primary outcomes
1
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Description
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Quality of wound healing
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Timepoint
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At the beginning of the study, measurements are taken on the second day, in week 2 and week 4.
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Method of measurement
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Wound healing index
2
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Description
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IL-6
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Timepoint
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At the beginning of the study, week 4 and week 12 measurements will be taken.
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Method of measurement
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Measurement of serum levels of IL-6
Secondary outcomes
1
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Description
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ESR
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Timepoint
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at the beginning of study, week 4, week 12
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Method of measurement
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Measurement of serum levels of ESR
2
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Description
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CRP
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Timepoint
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at the beginning of the study, week 4, week 12
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Method of measurement
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Measurement of serum levels of CRP
3
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Description
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TNF-a
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Timepoint
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at the beginning of the study, week 4, week 12
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Method of measurement
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Measurement of serum levels of TNF-a
4
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Description
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CBC
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Timepoint
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at the beginnig of the study, week 4, week 12
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Method of measurement
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Blood test
Intervention groups
1
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Description
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Intervention group: The intervention group will receive 3.3 grams of trehalose daily, (less than two-thirds of a teaspoon) after breakfast for 12 weeks (received a box containing about 280 g)The trehalose hydrate form, with a chemical formula of C12H22O11•2H2O, purity≥99%, and low metal ion content, will be procured from LeSen Biotechnology Co.
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Category
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Rehabilitation
2
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Description
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Control group: The control group will receive 3.3 grams of sucrose daily (less than two-thirds of a teaspoon) after breakfast for 12 weeks (received a box containing about 280 grams). Sucrose with the formula C12H22O11 will be procured from pharmaceutical equipment companies.
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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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Shahid Beheshti 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available