Determinig the effectiveness of vitamin C intake in patients diagnosed with rotator cuff tears undergoing arthroscopic treatment
Design
This is a prospective, monocentric randomized study approved by the Kerman University of Medical Science Ethical Committee. The randomization process was carried out by year of birth: patients born in an even number year received postoperative VC supplementation at a dose of 500 mg per day orally for 45 days (VC+ group) and patients born in an odd number year received no supplementation (VC−group). .
Settings and conduct
We included all patients who underwent arthroscopic a primary rotator cuff repair. The patients are then, divided into two groups. Preoperatively, then at 45 days, 3 months and 6 months, active mobility is measured using a goniometer. Also, the standardized shoulder evaluation form of american shoulder and elbow surgeons and the visual analogue scores preoperation and 6 months after the operation were determined. the participant and the evaluator are blinded. In this research, placebo is used and then vitamin C and the placebo are divided into two groups, A and B.
Participants/Inclusion and exclusion criteria
All paitents undergoing arthroscopic treatment due to rotator cuff tendon tear in year 1402- 1403 will enter the study
The exclusion criteria were a retraction of at least one tendon superior or equal to grade 3, fatty degeneration of at least one muscle superior or equal to grade 3, an anatomically non-repairable tear, and an isolated injury of the subscapular (Ssc) tendon. Patients without a clinical and ultrasound evaluation at a minimum follow-up of 6 months were excluded.
Intervention groups
Vitamin C + group in which they recieve vitamin C supplement 500mg per day, oral, for 45 days
Main outcome variables
Pain; Rotator Cuff tendon range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231021059783N1
Registration date:2023-11-19, 1402/08/28
Registration timing:prospective
Last update:2023-11-19, 1402/08/28
Update count:0
Registration date
2023-11-19, 1402/08/28
Registrant information
Name
Ghazal Ejlali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 0312
Email address
gh.ejlali@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-25, 1402/10/04
Expected recruitment end date
2024-04-23, 1403/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of vitamin C intake in patients diagnosed with rotator cuff tears undergoing arthroscopic treatment
Public title
Evaluating the effectiveness of vitamin C intake in patients diagnosed with rotator cuff tears undergoing arthroscopic treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All paitents undergoing arthroscopic treatment due to rotator cuff tendon tear in year 1402- 1403 after having signed the consent form will enter the study
Exclusion criteria:
A retraction of at least one tendon superior or equal to grade 3
Fatty degeneration of at least one muscle superior or equal to grade 3
An anatomically non-repairable tear
An isolated injury of the subscapular tendon
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
131
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the participant and the evaluator are blinded.
In this research, placebo is used. We use a similar product in terms of color, size, flavor, scent and other characteristics similar to vitamin C. Vitamin C and the placebo are divided into two groups, A and B, and neither the participant nor the evaluator knows which group is the placebo and which is vitamin C.
Placebo
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
Pardis of Medical University of Kerman, Haft Bagh Alavi Blvd. Kerman, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-10-15, 1402/07/23
Ethics committee reference number
IR.KMU.AH.REC.1402.122
Health conditions studied
1
Description of health condition studied
Rotator Cuff tear
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Pre operation, 6 months post-operation
Method of measurement
Yes-No questions based on American Shoulder and Elbow Surgeons questionare and Visual Analogue Scale
2
Description
Rotator Cuff tendon range of motion
Timepoint
Pre operation, 45 days post-operation, 3 months post-operation, 6 months post-operation
Method of measurement
Based on American Shoulder and Elbow Surgeons questionare and Goniometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin C + group in which they recieve vitamin c supplement 500mg per day, oral, for 45 days
Category
Treatment - Drugs
2
Description
Control group: Vitamin C - group in which they wont recieve any kind of supplement
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Ghazal Ejlali
Street address
Shafa Hospital, Kowsar Blvd. Kerman, Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
shafahospital@kmu.ac.ir
Web page address
https://sh.kmu.ac.ir/fa
2
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Ghazal Ejlali
Street address
Shahid Bahonar Hospital, Gharani St. Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
gh.ejlali@kmu.ac.ir
Web page address
https://bh.kmu.ac.ir/fa
3
Recruitment center
Name of recruitment center
Razieh Firooz Hospital
Full name of responsible person
Ghazal Ejlali
Street address
Razieh Firooz Hospital, West Motahari Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7615866991
Phone
+98 34 3222 8484
Email
info@rfhospital.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iran Pour
Street address
Ebn-e-Sina St. Jahad Blvd. Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
VCR@KMU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ghazal Ejlali
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Afzali Pour Medical College, Shahid Bahonar University, 22Bahman Blvd. Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3132 0500
Email
gh.ejlali@gmail.com
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
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Bahonar Hospital, Gharani St. Kerman, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
drsadeghifar2000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ghazal Ejlali
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Afzali Pour Medical College, Shahid Bahonar University, 22 Bahman Blvd. Kerman, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3132 0500
Email
gh.ejlali@gmail.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
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