Objective: To assess the effect of vitamin D supplementation on blood pressure in hypertensive patients with vitamin D deficiency (2)Design: Parallel randomized controlled double blind trial (3)Setting and conduct: After obtaining inform consent, the patients were randomized into two groups receiving vitamin D3 or placebo pearl using table of random numbers, blood pressure was measured and compared before and after the intervention between two groups (4)Participants including major eligibility criteria:42 hypertensive patients with vitamin D deficiency(serum 25-hydroxy vitamin D lower than 30 nmol/lit) referring to Azadshahr Health and treatment center in yazd (Iran) (5)Intervention: Receiving 50000 IU vitamin D3 supplementation (group1) or placebo(group2) for 8 weeks(one pearl per week) (6)Main outcome measures: Hypertension
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012090310724N1
Registration date:2012-09-25, 1391/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-25, 1391/07/04
Registrant information
Name
Saba Loloei
Name of organization / entity
Shahid Sadoogi University Of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 5900
Email address
saba.loloei@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoogi University of Medical Sciences and Health Services
Expected recruitment start date
2012-09-23, 1391/07/02
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation on blood pressure in hypertensive patients with vitamin D deficiency
Public title
The effect of vitamin D supplementation on blood pressure in hypertensive patients with vitamin D deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with Systolic Blood Pressure equal or more than 140 mmHg ; and Diastolic Blood Pressure equal or more than 90 mmHg. ; and serum 25-hydroxy vitamin D3 lower than 30 ng/ml ; living in Yazd province; aged 25-50 years; not to be alcohol user or smoker or addicted ; without any liver or Coronary-artery or renal or Gastro Intestinal disorders; not using oral or injection of corticosteroids; not using cardiac glycosides or antiepileptic drugs; not using multi vitamins or supplements containing vitamin D, Calcium, Magnesium, Phosphorus or their analogs in past 3 mounts; not using injection of vitamin D in past 6 mounts; Exclusion criteria: any change in dosage or type of anti hypertension drugs; not following the study protocol.
Exclusion criteria: any change in dosage or type of anti hypertension drugs; not following the study protocol.
Age
From 25 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Moral Committee of Shahid Sadoogi University of Medical Sciences and Health Services
Street address
Bahonar sq
City
Yazd
Postal code
Approval date
2012-07-28, 1391/05/07
Ethics committee reference number
61670/1/17/پ
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
hypertension
Timepoint
before and 8 week after intervention
Method of measurement
mercurial sphygmomanometer
Secondary outcomes
1
Description
serum Calcium
Timepoint
before and 8 weeks after intervention
Method of measurement
laboratory biochemical measurements
2
Description
serum 25- Hydroxy vitamin D
Timepoint
before and 8 weeks after intervention
Method of measurement
laboratory biochemical measurements _nmol/lit
3
Description
serum PTH
Timepoint
before and 8 weeks after intervention
Method of measurement
laboratory biochemical measurements
4
Description
serum phosphorus
Timepoint
before and 8 weeks after intervention
Method of measurement
laboratory biochemical measurements
Intervention groups
1
Description
50000IU vitamin D3 pearl(oral supplements),for 8 weeks, one pearl per week
Category
Treatment - Drugs
2
Description
placebo pearl, for 8 weeks, one pearl per week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
AZAD SHAHR health and treatment center of YAZD
Full name of responsible person
Dr Mohammadreza Mirjalili
Street address
Safaeie St.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Sadoogi University of Medical Sciences
Full name of responsible person
Dr Hassan Mozaffari Khosravi
Street address
Bahonar sq
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Sadoogi 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
Shahid sadoogi University Of Medical Sciences and Health Services
Full name of responsible person
Dr Mohammadreza Mirjalili
Position
specialist
Other areas of specialty/work
Street address
Bahonar sq
City
Yazd
Postal code
Phone
+98 35 1724 0172
Fax
Email
drmirjalili@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoogi University Of Medical Sciences and Health Services
Full name of responsible person
Dr Hassan Mozaffari Khosravi
Position
PHD, nutrition
Other areas of specialty/work
Street address
Bahonar Sq
City
Yazd
Postal code
Phone
+98 131531467
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoogi University Of Medical Sciences and Health Services
Full name of responsible person
Saba Loloei
Position
MS student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
City
Yazd
Postal code
Phone
00
Fax
Email
saba.loloei@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)