Effects of combined dietary supplementation of protein and creatine on outcomes and acceleration of postoperative recovery in patients with peritrochantic fracture: A double-blind interventional esoteric study
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General information
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اصلاح و به روز رسانی تاریخ شروع و اتمام کار آزمایی
اصلاح و به روز رسانی تاریخ شروع و اتمام کار آزمایی و اصلاح حجم نمونه
اصلاح و به روز رسانی تاریخ شروع و اتمام کار آزمایی و اصلاح حجم نمونه
Protocol summary
Study aim
Finding a better treatment and a more effective method in reducing the rate of postoperative hospitalization, readmission rate due to complications associated with peritrochantic fracture, mortality rate 30 days after surgery, one-year mortality rate and the mentioned complications.
Design
Two groups including control and intervention; each 45 participants; randomized with table
Settings and conduct
Ninety patients with peritrochantric fracture referred to Sina and Imam Khomeini Hospital in Tehran will be collected and complementary-placebo drug envelopes will be given to patients for up to 30 days.
The study is randomized and triple blind includes researcher and patient and pharmaceutical company.
Participants/Inclusion and exclusion criteria
Inclusion conditions: patients with intertroch fractures and femur neck and subtroch who will be referred to Sina Hospital or Imam Khomeini Hospital in Tehran.
Exclusion criteria: pregnancy; under 18 years of age; renal failure
Intervention groups
90 patients with peritrochanteric fracture were randomly divided into 2 intervention and control groups of 45 people each and received drug packets containing supplements or placebo. Laboratory and demographics and complications will be collected and compared before and one month after receiving the supplement.
Main outcome variables
Lymphocyte and CRP levels, Prealbumin and vitamin D levels - Quality of life - 30-day mortality - Interval between hospitalization and surgery - Delirium - Clinical venous thrombosis
General information
Reason for update
Correcting and updating the start and end date of the trial
Acronym
ERAS
IRCT registration information
IRCT registration number:IRCT20230127057247N1
Registration date:2023-08-12, 1402/05/21
Registration timing:registered_while_recruiting
Last update:2025-02-03, 1403/11/15
Update count:2
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
mohammad reza donyazad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6697 0295
Email address
dr.mrdonyazad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2024-08-01, 1403/05/11
Actual recruitment start date
2023-08-01, 1402/05/10
Actual recruitment end date
2024-08-01, 1403/05/11
Trial completion date
2024-09-01, 1403/06/11
Scientific title
Effects of combined dietary supplementation of protein and creatine on outcomes and acceleration of postoperative recovery in patients with peritrochantic fracture: A double-blind interventional esoteric study
Public title
Effects of combined dietary supplementation of protein and creatine on outcomes in patients with peritrochanter fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Femur neck fracture or intertroch fracture or subtrochantric fracture
Exclusion criteria:
Under 18 y/o
Pregnancy
Renal failure
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random numbers table
Blinding (investigator's opinion)
Triple blinded
Blinding description
The supplement and placebo are blinded by the manufacturer in English letters and the patient, the executor, the researcher and the manufacturer are unaware of the complete collection of the fear and its data from receiving the supplement or placebo by the patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical Science research committe ethics
Street address
6th Floor, Central Building, Tehran University of Medical Sciences, Qods Street Intersection, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1111854767
Approval date
2022-09-23, 1401/07/01
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.212
Health conditions studied
1
Description of health condition studied
Femoral neck fracture, intertroch fracture and subtroch of femoral fracture
ICD-10 code
S72.14
ICD-10 code description
Intertrochanteric fracture of femur
Primary outcomes
1
Description
Nutritional level by checking blood lymphocyte level changes
Timepoint
At the time of hospitalization and a month later
Method of measurement
Request for testing at the time of hospitalization and one month later
2
Description
Nutritional level by checking changes in blood albumin level
Timepoint
At the time of hospitalization and a month later
Method of measurement
Request for testing at the time of hospitalization and one month later
3
Description
Nutritional level by checking changes in blood CRP level
Timepoint
At the time of hospitalization and a month later
Method of measurement
Request for testing at the time of hospitalization and one month later
4
Description
Changes in quality of life and the ability to perform daily activities and walk
Timepoint
At the time of hospitalization and a month later
Method of measurement
Parker questionnaire
5
Description
30-day mortality
Timepoint
30 days after surgery
Method of measurement
questionnaire
6
Description
Time interval between hospitalization and surgery
Timepoint
Hospitalization day and surgery day
Method of measurement
questionnaire
7
Description
Complications occurred for the patient including delirium and clinical venous thrombosis
Timepoint
In 30 days after surgery
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: including patients with pretrochanteric fractures (femoral neck, intertrochanteric and subtrochanteric) referred to Sina and Imam Khomeini Hospital in Tehran, after removing excluded cases according to the randomization table, they were divided into 2 groups. In the intervention group, after collecting demographic information and The request for tests includes cbc-crp-albumin-pre-albumin. Depending on the location and type of fracture and the clinical conditions, the patient is subjected to internal surgical fixation, and then after discharge for one month, a daily dose of 30 mg protein sachets dissolved in water, which includes He consumed creatinine, essential amino acids and protein, and after a month, the patient will be asked for the aforementioned tests and will be analyzed.
Category
Treatment - Drugs
2
Description
Control group: including patients with peritrochanteric fractures (femoral neck, intertrochanteric and subtrochanteric) referring to Sina and Imam Khomeini Hospital in Tehran, after removing excluded cases, according to the randomization table, they were divided into 2 groups, in the control group, after collecting demographic information and Request for tests including cbc-crp-albumin-pre-albumin surgery depending on the location and type of fracture and the clinical conditions of the patient is subjected to internal surgical fixation and then after discharge for a month daily placebo protein sachets of 30 mg soluble in water which includes dextrose and after a month, the patient will be asked for the above-mentioned tests and will be analyzed. The table of the amount of starting the park before and after the surgery was completed for him in a comparative manner.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina & Imam Khomeini Hospital in Tehran
Full name of responsible person
Mohammad Reza Donyazad
Street address
End of Keshavarz Boulevard, Dr. Gharib, Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2253
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Bagheri
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8897 8745
Email
info@tpcf.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Donyazad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
the end of Keshavarz Boulevard, Dr. Gharib Street; Imam Khomeini Hospital Complex (RA) - Orthopedic Department
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6697 0295
Email
dr.mrdonyazad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Donyazad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
the end of Keshavarz Boulevard, Dr. Gharib Street; Imam Khomeini Hospital Complex (RA) - Orthopedic Department
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6697 0295
Fax
Email
dr.mrdonyazad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Donyazad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
The end of Keshavarz Boulevard, Dr. Gharib Street; Imam Khomeini Hospital Complex (RA) - Orthopedic Department
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6697 0295
Fax
Email
dr.mrdonyazad@yahoo.com
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