The aim of this study was to evaluate the effect of vitamin D in the treatment of patients after carpal tunnel syndrome surgery
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 105 patients. Balanced block randomization method was used for randomization. In this method, sextuple blocks were used for random placement of participants in the study.
Settings and conduct
The study was performed in the orthopedic ward of Golestan and Imam Khomeini hospitals in Ahvaz. Patients were divided into three groups. The patients in the first group received 1000 units of vitamin D daily, the patients in the second group received 2,000 units per week for 2-3 weeks, and then 3,000 units of vitamin D per month. The third group of patients did not receive any vitamin D supplementation. Blinding was performed without informing the patient and the therapist about the type of drug prescribed (double-blind).
Participants/Inclusion and exclusion criteria
Carpal tunnel surgery
Intervention groups
Patients were divided into three groups. The patients in the first group received 1000 units of oral vitamin D daily, the patients in the second group received 2,000 units per week for 2-3 weeks, and then 3,000 units of oral vitamin D per month. The third group of patients did not receive any vitamin D supplementation.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180313039085N2
Registration date:2021-06-15, 1400/03/25
Registration timing:retrospective
Last update:2021-06-15, 1400/03/25
Update count:0
Registration date
2021-06-15, 1400/03/25
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6683 0007
Email address
tramim@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2021-05-22, 1400/03/01
Trial completion date
2021-05-22, 1400/03/01
Scientific title
Evaluation of the effect of different doses of vitamin D on the prognosis of patients after carpal tunnel syndrome syndrome
Public title
The effect of vitamin D in improving carpal tunnel syndrome after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Carpal tunnel release surgery
Exclusion criteria:
Patients' unwillingness to participate in the study
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Actual sample size reached:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization method was used for randomization. In this method, sextuple blocks were used for random placement of participants in the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Golestan Hospital
Street address
No. 10, West Azadi Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-10-28, 1399/08/07
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.109
Health conditions studied
1
Description of health condition studied
Carpal Tunnel Syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
Pain
Timepoint
At the beginning of the study (before the intervention) and 6 months after vitamin D administration
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group I: The treatment involves the administration of an oral vitamin D pill. One tablet of 1000 units per day was prescribed for a period of six months. Its chemical composition is cholecalciferol, also known as vitamin D3. This drug is a dietary supplement that is produced in doses of 1000 units and 50,000 units by Ramofarmine Pharmaceutical Company. This drug in a dose of 1000 units can be taken daily and orally. It can be consumed in a dose of 50,000 units weekly and monthly.
Category
Treatment - Drugs
2
Description
Intervention group II: The treatment involves the administration of an oral vitamin D pill. One 50,000-unit vitamin D tablet was administered weekly for 4-6 weeks and then monthly for six months. Its chemical composition is calciferol, also known as vitamin D3. This drug is a dietary supplement that is produced in doses of 1000 units and 50,000 units by Ramofarmine Pharmaceutical Company. This drug in a dose of 1000 units can be taken daily and orally. It can be consumed in a dose of 50,000 units weekly and monthly.
Category
Treatment - Drugs
3
Description
Control group: Not receiving medication
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Karim Nourizadeh
Street address
No. 10, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
3311861357
Phone
+98 61 3374 3001
Email
golestanhospital@ajums.ac.ir
Web page address
https://hgolestan.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Aghdam
Street address
No. 10, West Azadi Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Web page address
https://vchresearch.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Karim Nourizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No. 10, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
3311861357
Phone
+98 61 3374 3001
Email
Karimnoorizadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Karim Nourizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No. 10, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
3311861357
Phone
+98 61 3374 3001
Email
Karimnoorizadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Karim Nourizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
No. 10, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
3311861357
Phone
+98 61 3374 3001
Email
Karimnoorizadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not 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
Article
When the data will become available and for how long
One year later
To whom data/document is available
All
Under which criteria data/document could be used
Published
From where data/document is obtainable
Data bank
What processes are involved for a request to access data/document