The frequency of mortality and morbidity following intertrochanteric fracture in patients over 60 years of age who received vitamin D compared to controls
The aim of this study was to compare patients in intervention and control groups regarding changes in serum vitamin D levels, complications and mortality after intertrochanteric fracture
Design
In this clinical trial, people who refer to the orthopedic ward of Besat Hospital in Hamadan with a hip fracture first patients' vitamin D levels will be measured. If the serum level of vitamin D is less than 20 ng / ml, patients will be randomly assigned to one of the intervention or control groups using a sealed envelope.
Settings and conduct
A non-blinding study will be performed on patients over 60 years of age with intertrochanteric hip fracture referred to Besat Hospital in Hamadan.
Participants/Inclusion and exclusion criteria
Participants in the study included patients over 60 years of age with intertrochanteric fractures of the hip joint with a serum vitamin D level less than 20 ng / ml. Patients with a history of previous pelvic fractures will be excluded from the study.
Intervention groups
]intervention group will receive 600,000 Units vitamin D supplement of muscle injection. The control group is not given vitamin D supplements.
Main outcome variables
The main outcome of the study will be effects of vitamin D supplementation on serum vitamin D levels, complications and mortality following iintertrochanteric fracture of the hip joint.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N14
Registration date:2021-02-13, 1399/11/25
Registration timing:registered_while_recruiting
Last update:2021-02-13, 1399/11/25
Update count:0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The frequency of mortality and morbidity following intertrochanteric fracture in patients over 60 years of age who received vitamin D compared to controls
Public title
The effect of vitamin D on complications and mortality of intertrochanteric fracture hip fracture in over 60 years patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years
Intertrochanteric fracture
Serum level of vitamin D less than 20 ng / ml
Exclusion criteria:
History of previous pelvic fractures
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
We made 80 cards and write letter I on 50 for Intervention and on the other 50 letter C for the control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and will be opened, based on selected letter I or C patients will be assigned to intervention or control group.
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 Hamadan Univercity of Medical Science
Street address
shahid fahmideh avenue
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2021-01-16, 1399/10/27
Ethics committee reference number
IR.UMSHA.REC.1399.868
Health conditions studied
1
Description of health condition studied
Intertrochanteric fracture
ICD-10 code
S72.14
ICD-10 code description
Intertrochanteric fracture of femur
Primary outcomes
1
Description
Changes in serum levels of vitamin D.
Timepoint
One year after the fracture
Method of measurement
Blood serum test
Secondary outcomes
1
Description
Complications following a fracture
Timepoint
Within a year after the fracture
Method of measurement
Physical examination
2
Description
mortality incidence after fracture
Timepoint
Within a year after the fracture
Method of measurement
Phone follow up
Intervention groups
1
Description
Intervention group: Receiving a vitamin D supplement in a vial of 600,000 units of single-dose intramuscular injection
Category
Prevention
2
Description
Control group: They will receive routine postoperative care without injecting vitamin D.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
dr Morteza Majidi
Street address
Shahid Beheshti Blvd
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr Saeid Bashirian
Street address
Shahid Fahmide Ave
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
shahid fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Morteza Majidi
Position
Associated professor pf orthpedia
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Blv
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3838 0092
Fax
Email
majidi57@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan shahid fahmideh street medicine school
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
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
No more information
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