Effect of vitamin D and C in preventing complex regional pain syndrome (CRPS) in distal extra-articular radius fractures in patients aged 40 to 70 years.
Determining the effect of vitamin D and C in preventing complex regional pain syndrome (CRPS) in distal extra-articular radius fractures in patients aged 40 to 70 years.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 250 patients. Randomization was done using the permuted block randomization method. Blocks of six will be produced using the online site (www.sealedenvelope.com).
Settings and conduct
A double-blind clinical trial study will be conducted on 250 patients with extra-articular fractures of the distal radius. Patients will be selected from the emergency department of Shahid Bahonar Hospital from May 2024 to May 2025 according to the inclusion and exclusion criteria. After obtaining informed consent patients will be assigned to treatment groups using the random blocks.
The first or control group will receive routine treatment and 500 mg of vitamin C daily, intervention groups: the second group will receive routine treatment and 1000 mg of vitamin D daily, and the third group will receive routine treatment and vitamin D and C daily. A questionnaire containing demographic and clinical information will be filled out for all patients. Then patients will be evaluated for CRPS symptoms 4, 8, and 12 weeks after the treatment.
In this study, the outcome evaluators and statistical analysts are unaware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with distal radius fracture, Age 40 to 70
Exclusion criteria: History of disorders in vitamin D metabolism, History of multiple fractures, History of previous distal radius fracture, History of autoimmune disease, History of open fracture
Intervention groups
The first group received 1000 mg of vitamin D daily.
The second group received 1000 mg of vitamin D and 500 mg of C daily
Main outcome variables
Complex regional pain syndrome (CRPS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240416061506N1
Registration date:2024-06-01, 1403/03/12
Registration timing:registered_while_recruiting
Last update:2024-06-01, 1403/03/12
Update count:0
Registration date
2024-06-01, 1403/03/12
Registrant information
Name
Shiva Pouradeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3273 9304
Email address
shivapooradeli@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D and C in preventing complex regional pain syndrome (CRPS) in distal extra-articular radius fractures in patients aged 40 to 70 years.
Public title
The effect of vitamins D and C in the prevention of complex regional pain syndrome in extra-articular distal radius fractures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People with distal radius fracture
Age 40 to 70
Exclusion criteria:
History of disorders in vitamin D metabolism
history of multiple fractures
History of previous distal radius fracture
History of autoimmune disease
History of open fracture
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
250
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization will be used for randomization. Blocks of six will be produced using the online site (www.sealedenvelope.com). In each block, all three treatments are randomly assigned to the patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome evaluator does not know the type of drug received
The data is provided to the data analyst in a coded form, and he does not know the type of drug received
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Vice Chancellor for Research., Ebn-e-Sina Ave., Kerman Town
City
Rafsanjan
Province
Kerman
Postal code
7619813159
Approval date
2024-04-17, 1403/01/29
Ethics committee reference number
IR.KMU.AH.REC.1402.172
Health conditions studied
1
Description of health condition studied
Extra-articular distal radius fractures
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius
Primary outcomes
1
Description
Complex Regional Pain Syndrome
Timepoint
The cause of trauma to the distal radius, type of treatment, and type of extra-articular fracture will be recorded. The patients will be evaluated 4, 8, and 12 weeks after the treatment in terms of symptoms of complex regional pain syndrome.
Method of measurement
Clinical examination and numerical pain rating scale (NPRS) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 1000 mg of vitamin D daily
Category
Treatment - Drugs
2
Description
Intervention group 2: 1000 mg of vitamin D and 500 mg of vitamin C daily
Category
Treatment - Drugs
3
Description
Control group: 500 mg of vitamin C daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahoner Hospital, Kerman
Full name of responsible person
Jamshid Abdi Nasab
Street address
Shahid Bahonar Hospital., Qaraney Ave., Kerman Town
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
abdinasab39@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin iranpour
Street address
Ebn-e-Sina Ave
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
a.iranpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Amir Reza Sadeghi Far
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Bahonar Hospital., Qaraney Ave., Kerman Town
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
sadeghifar@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amir Reza Sadeghi Far
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Bahonar Hospital., Qaraney Ave; KermanTown
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
sadeghifar@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shiva Pouradeli
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
No. 144, Atar Ave., Jahad Blvd., Kerman Town
City
Kerman
Province
Kerman
Postal code
7619839157
Phone
+98 34 3273 9304
Email
shivapooradeli@gmail.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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All the necessary precautionary measures are taken to protect the privacy of the subjects, to keep the information related to them confidential, and also to reduce the adverse effect of the study on the physical and mental health of the subjects. Non-identifiable data can be shared for re-analysis as presented in the thesis and article
When the data will become available and for how long
6 months after the thesis results are published,
3 months after the publication of the article
To whom data/document is available
Thesis professors and referees
Editor of the journal and reviewers of the article
Under which criteria data/document could be used
An official letter with a convincing reason for data access
From where data/document is obtainable
Coordination with Dr. Jamshid Abdi Nasab's thesis student via email abdinasab39@gmail.com
What processes are involved for a request to access data/document
Send request by email,
Official letter of request with signature and sufficient reasons,
Student coordination with hospital security,
Receive confirmation from the security,
Send information via email or CD