Objective: to assess the effect of vitamin D supplementation versus no intervention on primary hypertension;
Design: randomized controlled trial
Setting: eligible patients with primary hypertension who refer to Ekbatan hospital in 2012 will be enrolled in the study
Inclusion criteria: (a) age of 15 or greater; (b) having systolic blood pressure equal to or greater than 140 mmHg or diastolic blood pressure equal to or greater than 90 mmHg on two separate occasions.
Exclusion criteria: (a) having secondary hypertension; (b) having diabetes; (c) having chronic kidney disease; (d) being pregnant; (e) history of using of vitamin D or calcium during the last three months; (f) history of using Thiazide-type diuretics.
Intervention: 104 patients with primary hypertension will receive routine anti-hypertension medication plus oral soft gel of vitamin D supplementation (D3) 50,000 U one per week for three months.
Control: 104 patients with primary hypertension will receive routine anti-hypertension medication for three months.
Outcome: measurement of systolic and diastolic blood pressure in mmHg using mercury manometer and a stethoscope in setting position from right hand at baseline and monthly for three months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211239014N12
Registration date:2012-12-01, 1391/09/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-01, 1391/09/11
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on primary hypertension: a randomized clinical trial
Public title
Effect of vitamin D supplementation on primary hypertension: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 15 or greater; (b) having systolic blood pressure equal to or greater than 140 mmHg or diastolic blood pressure equal to or greater than 90 mmHg on two separate occasions.
Exclusion criteria: (a) having secondary hypertension; (b) having diabetes; (c) having chronic kidney disease; (d) being pregnant; (e) history of using of vitamin D or calcium during the last three months; (f) history of using Thiazide-type diuretics.
Age
From 18 years old to 149 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
208
Randomization (investigator's opinion)
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
Local human subject review board
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Approval date
2012-11-20, 1391/08/30
Ethics committee reference number
D-P-35-9-3029
Health conditions studied
1
Description of health condition studied
Primary hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Systolic blood pressure in mmHg
Timepoint
at baseline and monthly for three months
Method of measurement
Using mercury manometer and a stethoscope in setting position from right hand
2
Description
Diastolic blood pressure in mmHg
Timepoint
at baseline and monthly for three months
Method of measurement
Using mercury manometer and a stethoscope in setting position from right hand
Secondary outcomes
1
Description
Systemic adverse effect such as vomoting
Timepoint
Monthly for three months
Method of measurement
Through question
2
Description
ُystemic adverse effect such as nausea
Timepoint
Monthly for three months
Method of measurement
Through question
Intervention groups
1
Description
Routine anti-hypertension medication plus oral soft gel of vitamin D supplementation (D3) 50,000 U one per week for three months
Category
Treatment - Drugs
2
Description
Routine anti-hypertension medication for three months
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Dr Mohsen Gharrakhani
Street address
Ekbatan Hospital, Jahad Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Heidar Tavilani
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research Center for Health Sciences and Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
Research Center for Health Sciences and Department of Epidemiology & Biostatistics, School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Research Center for Health Sciences and Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
Research Center for Health Sciences and Department of Epidemiology & Biostatistics, School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave