Protocol summary

Study aim
Effect of vitamin D supplementation in regulation of blood pressure in essential hypertensive patients
Design
This study is a single-center, prospective, open-labeled,parallel phase 3 clinical trial.
Settings and conduct
Patients who visit the Baqiyatallah Hospital Clinic, which meets the inclusion criteria, will be divided into two intervention groups, based on vitamin D level.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Essential Hypertension (Systolic pressure > 140 mmHg, Diastolic pressure > 90 mmHg) Adult patients from 18 to 65 y/o Patients under standard Anti-hypertensive agents Vitamin D serum level less than 30. Exclusion Criteria Heart Failure (LVEF<45%) Renal Failure (Creatinine>1.5mg/dl) Hepatic Failure Chronic Obstructive Pulmonary Disease (COPD): (FEV1/FVC <70%) Thyroid disorders Hyperparathyroidism Systemic infection Hypercalciurea
Intervention groups
Intervention arm 1 : 5000 U vitamin D until 8 weeks (in addition to routine anti hypertensive drugs); intervention arm 2: 1000 U vitamin D until 8 weeks (in addition to routine anti hypertensive drugs)
Main outcome variables
Systolic blood pressure Diastolic blood pressure mean arterial pressure vitamin D3 level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080901001165N57
Registration date: 2020-05-27, 1399/03/07
Registration timing: retrospective

Last update: 2020-05-27, 1399/03/07
Update count: 0
Registration date
2020-05-27, 1399/03/07
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Chemical Injuries Research Center, Baqiyatallah University of Medical sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-06-09, 1394/03/19
Actual recruitment start date
2014-10-23, 1393/08/01
Actual recruitment end date
2015-06-22, 1394/04/01
Trial completion date
2015-06-22, 1394/04/01
Scientific title
Investigating the effect of vitamin D3 supplementation in blood pressure control in essential hypertensive patients
Public title
Effect of vitamin D supplement in regulation of blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Essential Hypertension (Systolic pressure > 140 mmHg, Diastolic pressure > 90 mmHg) Adult patients from 18 to 65 y/o Patients under standard Anti-hypertensive agents Vitamin D level is less than 30.
Exclusion criteria:
Heart Failure (LVEF<45%) Renal Failure (Creatinine>1.5mg/dl) Hepatic Failure Chronic Obstructive Pulmonary Disease (COPD): (FEV1/FVC <70%) Thyroid disorders Hyperparathyroidism Systemic infection Hypercalciurea
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 200
Actual sample size reached: 176
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Baqiyatallah University of Medical Sciences
Street address
South Sheikh-Bahaei St., Mollasadra St., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2015-04-19, 1394/01/30
Ethics committee reference number
IR.RMSU.REC.1394.31

Health conditions studied

1

Description of health condition studied
Essential hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
at baseline and 8 weeks after intervention
Method of measurement
Sphygmomanometer, mmHg

2

Description
Diastolic blood pressure
Timepoint
at baseline and 8 weeks after intervention
Method of measurement
Sphygmomanometer, mmHg

3

Description
Mean arterial pressure
Timepoint
at baseline and 8 weeks after intervention
Method of measurement
Sphygmomanometer, mmHg

4

Description
Vitamin D serum level
Timepoint
at baseline and 8 weeks after intervention
Method of measurement
ng/ml

Secondary outcomes

1

Description
Adverse effect of vitamin D supplement
Timepoint
8 weeks after treatment
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention arm 1 : Pearl vitamin D 50000 Unit,PO, weekly, for 8 weeks (in addition to routine anti hypertensive drugs);
Category
Treatment - Drugs

2

Description
Control group: Pearl vitamin D 1000 U, PO, daily, for 8 weeks (in addition to routine anti hypertensive drugs)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Yunes Panahi
Street address
South Sheikh-Bahaei St., Mollasadra St., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
Yunespanahi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Street address
South Sheikh-Bahaei St., Mollasadra St., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Email
Yunespanahi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chemical Injuries Research Center, Baqiyatallah 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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Javad Rostami-Yalmeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
South Sheikh-Bahaei St., Mollasadra St., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2516
Fax
Email
javadrostami67@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Chemical Injuries Research Center, Baqiyatallah University of Medical sciences
Full name of responsible person
Yunes Panahi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherapy
Street address
South Sheikh-Bahaei St., Mollasadra St., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 2516
Fax
Email
yunespanahi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parisa Kianpour
Position
assistant
Latest degree
Specialist
Other areas of specialty/work
Pharmacotherapy
Street address
Pharmacy faculty, Tehran University of medical science, 16-Azar St., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4709
Email
parisa_kianpour@yahoo.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
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
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