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Primary outcomes
#1
Inflammation
IL-6
InflammationIL-6
التهاب
اینترلوکین-۶
التهاباینترلوکین-۶
Measurement of serum levels of IL-6, ESR, CRP, TNF-a.
Measurement of serum levels of IL-6
Measurement of serum levels of IL-6, ESR, CRP, TNF-a.
اندازه گیری مقدار سرمی IL-6, ESR, CRP, TNF-a
اندازه گیری مقدار سرمی IL-6
اندازه گیری مقدار سرمی IL-6, ESR, CRP, TNF-a
Secondary outcomes
#1
empty
ESR
ESR
empty
سرعت رسوب گلبول های قرمز
سرعت رسوب گلبول های قرمز
empty
at the beginning of study, week 4, week 12
at the beginning of study, week 4, week 12
empty
ابتدای مطالعه، هفته چهارم، هفته دوازدهم
ابتدای مطالعه، هفته چهارم، هفته دوازدهم
empty
Measurement of serum levels of ESR
Measurement of serum levels of ESR
empty
اندازه گیری مقدار سرمی ESR
اندازه گیری مقدار سرمی ESR
#2
empty
CRP
CRP
empty
پروتیین واکنشی C
پروتیین واکنشی C
empty
at the beginning of the study, week 4, week 12
at the beginning of the study, week 4, week 12
empty
ابتدای مطالعه، هفته چهارم، هفته دوازدهم
ابتدای مطالعه، هفته چهارم، هفته دوازدهم
empty
Measurement of serum levels of CRP
Measurement of serum levels of CRP
empty
اندازه گیری مقدار سرمی CRP
اندازه گیری مقدار سرمی CRP
#3
empty
TNF-a
TNF-a
empty
فاکتور نکروز دهنده تومور آلفا
فاکتور نکروز دهنده تومور آلفا
empty
at the beginning of the study, week 4, week 12
at the beginning of the study, week 4, week 12
empty
ابتدای مطالعه، هفته چهارم، هفته دوازدهم
ابتدای مطالعه، هفته چهارم، هفته دوازدهم
empty
Measurement of serum levels of TNF-a
Measurement of serum levels of TNF-a
empty
اندازه گیری مقدار سرمی TNF-a
اندازه گیری مقدار سرمی TNF-a
#4
empty
CBC
CBC
empty
شمارش کامل خون
شمارش کامل خون
empty
at the beginnig of the study, week 4, week 12
at the beginnig of the study, week 4, week 12
empty
ابتدای مطالعه، هفته چهارم، هفته دوازدهم
ابتدای مطالعه، هفته چهارم، هفته دوازدهم
empty
Blood test
Blood test
empty
آزمایش خون
آزمایش خون
Protocol summary
Study aim
The main aim of the study is to investigate the effect of trehalose on inflammation and wound healing in humans.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
A diagnosis of peri-trochanteric fractures is the inclusion criterion for the study. Various chronic diseases, infections, and immunodeficiency are exclusion criteria.
Intervention groups
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.
Main outcome variables
Comparison of changes in wound healing and inflammation within each group and between the two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039188N5
Registration date:2024-07-07, 1403/04/17
Registration timing:prospective
Last update:2024-07-20, 1403/04/30
Update count:2
Registration date
2024-07-07, 1403/04/17
Registrant information
Name
Reza Zandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2560
Email address
reza.zandi@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the Effects of Trehalose Consumption on Inflammation and Wound Healing in Patients with Peri-Trochanteric Fractures
Public title
Effects of Trehalose on Peri-Trochanteric Fractures
Purpose
Supportive
Inclusion/Exclusion criteria
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)
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of school of medicine - Shahid Beheshti university of medical sciences
Street address
Taleghani Hospital, next to Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2024-06-18, 1403/03/29
Ethics committee reference number
IR.SBMU.MSP.REC.1403.191
Health conditions studied
1
Description of health condition studied
Peri-trochanteric fractures
ICD-10 code
S72.1
ICD-10 code description
Pertrochanteric fracture
Primary outcomes
1
Description
Quality of wound healing
Timepoint
At the beginning of the study, measurements are taken on the second day, in week 2 and week 4.
Method of measurement
Wound healing index
2
Description
IL-6
Timepoint
At the beginning of the study, week 4 and week 12 measurements will be taken.
Method of measurement
Measurement of serum levels of IL-6
Secondary outcomes
1
Description
ESR
Timepoint
at the beginning of study, week 4, week 12
Method of measurement
Measurement of serum levels of ESR
2
Description
CRP
Timepoint
at the beginning of the study, week 4, week 12
Method of measurement
Measurement of serum levels of CRP
3
Description
TNF-a
Timepoint
at the beginning of the study, week 4, week 12
Method of measurement
Measurement of serum levels of TNF-a
4
Description
CBC
Timepoint
at the beginnig of the study, week 4, week 12
Method of measurement
Blood test
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Reza Zandi
Street address
Erabi St. Danshjoo Blvd, Velenjak, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Fax
+98 21 2212 6238
Email
reza.zandi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasrin Khateri
Street address
Shahid Beheshti University of Medical Sciences, Koodakyar St., Danshjoo Blvd., Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 23871
Fax
+98 21 2243 9863
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Zandi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti University, Student blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Email
Reza.zandi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Zandi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti University, Student blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Email
Reza.zandi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Zandi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti University, Student blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1000
Email
Reza.zandi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available