Evaluation of the results of using vitamins D and C in the prevention of CRPS
Design
Phase 2 clinical trial in patients with acute distal radius fractures requiring fixation surgery that the control group does not have.
Settings and conduct
After the necessary evaluations, if the inclusion criteria are met, the patients are transferred to the operating room, closed, reduced and pinned, and then an external fixator is installed for them.
Participants/Inclusion and exclusion criteria
Distal radius fracture; ability to receive oral vitamins C and D; indication for fixation of distal radius fracture by external fixator and pin method; osteoporosis; patients with other fractures, ligament damage or neuropathy; previous fracture involved in the radius
Intervention groups
Patients aged 18 to 60 years with acute distal radius fracture require fixation surgery with external fixator and pin
Main outcome variables
Pain in the range of motion; amount of patient activity and surgical complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211201053235N6
Registration date:2022-06-20, 1401/03/30
Registration timing:prospective
Last update:2022-06-20, 1401/03/30
Update count:0
Registration date
2022-06-20, 1401/03/30
Registrant information
Name
Meisam Jafari Kafiabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
dr.jafari8567@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vitamin C and Vitamin D effect on distal radius fractures treated with external fixation+PCP
Public title
Treatment of distal radius fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Distal radius fracture
Ability to receive oral vitamins C and D
Indication for fixation of distal radius fracture by external fixator and pin method
Exclusion criteria:
Osteoporosis
Patients with other fractures, ligament damage or neuropathy
Previous fracture involved in the radius
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yemen Street, Shahid Chamran Highway, Iran, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-04-24, 1401/02/04
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.038
Health conditions studied
1
Description of health condition studied
Fracture at wrist and hand level
ICD-10 code
S62
ICD-10 code description
Fracture at wrist and hand level
Primary outcomes
1
Description
Pain
Timepoint
2 weeks, 6 weeks, 12 weeks and 6 and 12 months after surgery
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Range of motion
Timepoint
6 weeks, 12 weeks and 6 and 12 months after surgery
Method of measurement
Patient examination
Intervention groups
1
Description
Intervention group: Patients with distal radius fractures who were treated with pins and external fixators and found vitamins C and D after surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Dr. Meisam Jafari Kafiabadi
Street address
Tajrish square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
dr.jafari8567@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Yemen street, Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Meisam Jafari Kafiabadi
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Yemen street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
dr.jafari8567@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farsad Biglari
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Yemen street, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
biglari.farsad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Meisam Jafari Kafiabadi
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Shohada-e tejrish hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2271 8000
Email
dr.jafari8567@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After finishing patient recruitment
When the data will become available and for how long
After finishing patient recruitment
To whom data/document is available
After finishing patient recruitment
Under which criteria data/document could be used
After finishing patient recruitment
From where data/document is obtainable
After finishing patient recruitment
What processes are involved for a request to access data/document