compare the alteration of vitamin D deficiency in patients candidate for bariatric surgery with vitamin D defeciency in varous methods oral ,injection and mix of two methods in azahra hospital in esfahan.
1. A survey and compare to average of vitamin D level in patients candidate for bariatric surgery with vitamin D deficiency before and after receive vitamin D supplement into oral and injection and mix of two methods.
2. Determine amount of cooperation in patients candidate for bariatric surgery with vitamin D deficiency before surgery into oral and injection and mix of two methods.
Design
A concealed with no control groups , based on society and pragmatic, parallel groups, one side blinded,randomized.
Settings and conduct
This study done in alzahra hospital in esfahan on patients candidate for Bariatric surgery who have vitamin D deficiency. Give them defined amount of vitamin D supplement and check the vitamin D , level again and record. Study was one side blinded.
Participants/Inclusion and exclusion criteria
Entrance terms patients candidate for Bariatric surgery with vitamib D deficiency and interst to cooperate in this project.
Nonentrance terms ; patients who didnot candidate for bariatric surgery or candidate for bariatric surgery but have normal level of vitamib D and indisposition to cooperate in project
Intervention groups
A study to altertion of vitamin D level after advising vitamin supplement in to oral in group 1
A study to altertion of vitamin D level after advising vitamin supplement in to lnjection in group 2
A study to altertion of vitamin D level after advising vitamin supplement in to mix of two methods in group 3
Main outcome variables
Vitamin D level in obes patient
General information
Reason for update
Acronym
EVS
IRCT registration information
IRCT registration number:IRCT20180312039067N1
Registration date:2018-06-29, 1397/04/08
Registration timing:retrospective
Last update:2018-06-29, 1397/04/08
Update count:0
Registration date
2018-06-29, 1397/04/08
Registrant information
Name
masoud sayadi shahraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3667 1832
Email address
sayadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
2016-03-20, 1395/01/01
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
empty
Scientific title
compare the alteration of vitamin D deficiency in patients candidate for bariatric surgery with vitamin D defeciency in varous methods oral ,injection and mix of two methods in azahra hospital in esfahan.
Public title
A survey to compare the alteration of vitamin D deficiency in patients candidate for bariatric surgery with vitamin D deficiency in varous methods oral, injection and mix of two methods in azahra hospital in esfahan.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patiens candidate bariatrics surgery
Vitamin D deficiency
Exclusion criteria:
No candidation for bariatric surgery
Normal level of vitamin D
Dissatisfaction
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
99
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized-indiviual-random
Patients with qualify to research get one of the methods of supplement randomized and random.
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 Esfahan University of Medical Sciences
Street address
hezar jarib ave, medical faculity ,ethics committee
City
Esfehan
Province
Isfehan
Postal code
8174673461
Approval date
2017-01-21, 1395/11/02
Ethics committee reference number
. IR.MUI.REC.1395.3.765
Health conditions studied
1
Description of health condition studied
Endocrine, nutritional and metabolic diseases
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency
Primary outcomes
1
Description
vitamin D level in obes patients
Timepoint
To measure of vitamin D level before and after supplement reciept (6 weeks later)
Method of measurement
Vitamin D level in blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: : Give to group1 ,six pearl of vit D 50000 IU week one for six weeks
Category
Treatment - Drugs
2
Description
Intervention group: give to group2 , one vit D ampoul 300000 IU
Category
Treatment - Drugs
3
Description
Intervention group: give to group3 , 3 vit D pearl 50000IU week one for three weeks and half of the vit D ampoule 300000 IU for the next three weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Masoud sayadi
Street address
Alzahra hospital , soffe Blvd
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
sayadi@med.mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahbobe shojaei
Street address
Isfahan university of medical sciences ,isfahan ,iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sayadi@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Number5 , Mahan Convened, West aban alley ,Kharazmi avenue, Sepahanshahr
City
Isfahan
Province
Isfehan
Postal code
6816744111
Phone
+98 31 3651 8499
Email
sayadi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Number5 , Mahan convened, West aban alley ,Kharazmi avenue, Sepahanshah
City
Isfahan
Province
Isfehan
Postal code
6816744111
Phone
+98 31 3651 8499
Email
sayadi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Sayadi
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Number5 , Mahan convened, West aban alley ,Kharazmi avenue, Sepahanshahr
City
Isfahan
Province
Isfehan
Postal code
6816744111
Phone
+98 31365184998
Email
sayadi@med.mui.ac.ir
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