Evaluation the bloodpressure in patients with pre_hypertention and deficiency of vitamin D 6 that are reffered to fajr clinic of mostafa khomeini hospital.
Evaluation the bloodpressure in patients with pre_hypertention that are reffered to fajr clinic of mostafa khomeini hospital before and after treatment of vitamin D deficiency
Design
134 patients that are between 30 to 70 years old with prehypertention and vit D is lower than 30 ng/ml
Settings and conduct
This study is on 134 patients between 30 to 70 years old that are refered to mostafa khomeini hospital in ilam. At first the bloodpressure is measured and if they dont have infication for begining the treatment and dont use drugs for bloidpresdure then we measure vit d and if it is lower than 30 ng/ml we treat the defiency of vitamin d according to protocol and revognize the changes
Participants/Inclusion and exclusion criteria
Age between 30 to 70 years old
Systolic bloidpresdure 120-139 and diastolic 80-89
Vitamin D is lower than 30 ng/ml
Intervention groups
134 patients that are between 30 to 70 years old with prehypertention
Main outcome variables
Vitamin d and bloodpresdure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221026056306N1
Registration date:2022-11-14, 1401/08/23
Registration timing:registered_while_recruiting
Last update:2022-11-14, 1401/08/23
Update count:0
Registration date
2022-11-14, 1401/08/23
Registrant information
Name
Roya Yalamealiabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3423 9877
Email address
royaylm79@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-01, 1401/05/10
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the bloodpressure in patients with pre_hypertention and deficiency of vitamin D 6 that are reffered to fajr clinic of mostafa khomeini hospital.
Public title
Vitamin D in prehypertention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30 to 70 years old
Systolic bloodpresdure 120-139 and diadtolic bloodpressure 80-89
Vitamin d is lower than 30 ng/ml
Exclusion criteria:
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
134
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences
Street address
The south ave, 38 court,Borujen Town
City
Borujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871946556
Approval date
2022-07-27, 1401/05/05
Ethics committee reference number
IR.MEDILAM.REC.1401.082
Health conditions studied
1
Description of health condition studied
Prehypertention
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percent of people with systolic bloodpressure 120-139 and diastolic 80-89
Timepoint
Measurement of bloodpressure in begining of study and 6 weeks after treatment of vitamin d
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
1
Description
Vitamin d
Timepoint
Beginng of study and 6 weeks after treatment of vitsmin d deficiency
Method of measurement
ELISA test
Intervention groups
1
Description
Intervention group: for 6 weeks and every week one pearl of vitamin d 50000
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
کلینیک فجر بیمارستان مصطفی خمینی
Full name of responsible person
Doctor asker sofinia
Street address
Shahid keshvari square, Mostafa khomeini hospital, Ilam Town
City
Ilam
Province
Ilam
Postal code
8871946556
Phone
+98 84 3336 4862
Email
royaylm79@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Doctor abbas maleki
Street address
Banganjab,Medical University of Ilam
City
Ilam
Province
Ilam
Postal code
8871946556
Phone
+98 933 088 9515
Email
royaylm79@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
asker sofinia
Position
Medical doctor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Keshvari square , mostafa khomeini hospital
City
Ilam
Province
Ilam
Postal code
8871946556
Phone
+98 38 3423 9877
Email
royaylm79@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Roya yalame
Position
Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
The south razi ave,38 court,botujen town
City
Borujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871946556
Phone
+98 38 3423 9877
Email
royaylm79@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Rora yalame
Position
Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
The south razi ave,38 court,borugen town
City
Borugen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871946556
Phone
+98 38 3423 9877
Email
royaylm70@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
Yes - There is 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
Title and more details about the data/document
This dates will be gathered from patients
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
For rehers in university
Under which criteria data/document could be used
For research
From where data/document is obtainable
Roya yalame 09330889515
What processes are involved for a request to access data/document
By my email the dates will be accessible in one week