Effect of vitamin D on grip power in menopausal women with distal radius fracture
Design
This study is a clinical trial which will be conducted on postmenopausal women with Distal Radius Fractures. The sample size is computed to be 42 clients in each group according to previous studies, and 95% confidence level.Patients will randomly be divided into two intervention and control groups.
Settings and conduct
This study will be conducted at Imam Khomeini hospital in Sari, Iran. Patients will enter the study after obtaining informed consent and according to inclusion and exclusion criteria they will be divided into two groups of intervention and control by random numbers table. The Grip strength will be measured by the dynamometer. According to the patient's pain and the likelihood of their lack of cooperation, grip strength will be measured in the opposite hand, according to 10% law, grip strength of broken hand will be 10% less than healthy hand. Then Vitamin D 50,000 units will be administrated every 4 weeks for 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Menopausal women aged over 50 years؛ Fracture of the end of radius؛ levels of vitamin D before surgery 30 -100ng / ml؛ Patient's informed consent to participate in the study؛ No treatment in the last 6 months; Exclusion criteria: Digestive diseases؛ Kidney diseases such as acute and chronic failure and ESRD؛ Rheumatic diseases
Intervention groups
Intervention group: Vitamin D, 50,000 units, every 4 weeks for 3 months.
Control group:No Vitamin D will be administrated.
Main outcome variables
Grip power
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160830029603N7
Registration date:2018-07-12, 1397/04/21
Registration timing:registered_while_recruiting
Last update:2018-07-12, 1397/04/21
Update count:0
Registration date
2018-07-12, 1397/04/21
Registrant information
Name
Masoud Shayestehazar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3304 4859
Email address
shayestehazar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitamin D on Grip Power in Menopausal Women with Distal Radius Fractures
Public title
Effect of Vitamin D on Grip Power in Menopausal Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal women aged over 50 years.
Fracture of the end of radius
Level of vitamin D equal to 30 -100ng/ml before surgery
Patient's informed consent to participate in the study
No treatment in the last 6 months
Exclusion criteria:
Digestive diseases
Kidney diseases such as acute and chronic failure and ESRD
Rheumatic diseases
Patients with traumatic, neoplastic or infectious lesions
history of surgery
History of Diabetes
History of disabling background problems
Age
From 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using Random Numbers Table
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, First of Vali Asr high way, Joibar three way, Emam Sq.
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1396.3079
Health conditions studied
1
Description of health condition studied
Distal Radius Fracture
ICD-10 code
S52.5
ICD-10 code description
Fracture of lower end of radius
Primary outcomes
1
Description
Grip strength
Timepoint
Measure the grip strength of the patients before the intervention and 2, 6, 12, 24 weeks after administration of vitamin D
Method of measurement
dynamometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin D 50,000 units every 4 weeks for 3 months
Category
Treatment - Drugs
2
Description
Control group:No Vitamin D will be administrated
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Masoud Shayestehazar
Street address
Mazandaran University of Medical Sciences, Beginning of Valiasr Highway, Joybar three way
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3304 4001
Email
mshayestehazar@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Ahmad Ali Enayati
Street address
Deputy of Research and Technology of Mazandaran University of Medical Science, Moalem Sq., Moalem St., Sari
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3337 7169
Email
mshayestehazar@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Masoud Shayesteh Azar
Position
Hip Surgery Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Mazandaran University of Medical Sciences, First of Vali Asr high way., Joibar three way, Emam Sq., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 7169
Fax
Email
shayestehazar@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Masoud Shayesteh Azar
Position
Hip Surgery Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Mazandaran University of Medical Sciences, First of Vali Asr high way., Joibar three way, Emam Sq., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 7169
Fax
Email
shayestehazar@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Doctor Abolfazl Kazemi
Position
orthopedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Mazandaran University of Medical Sciences, First of Vali Asr high way., Joibar three way, Emam Sq., Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3337 7169
Fax
Email
shayestehazar@mazums.ac.ir
Web page address
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