120 healthy non surgical postmenopausal women without serious diseases such as cardiovascular , diabetes mellitus with vitamin D insufficiency (defined as a 25-[OH] D level < 75 nmol/L) were randomly assigned to receive placebo or vitamin D3 2000 IU once daily. The patients will assessed for fasting lipid profile, FBS, blood pressure, weight and BMI before and after 12 weeks of treatment. Data is analyzed using t-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091810868N1
Registration date:2012-10-09, 1391/07/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-09, 1391/07/18
Registrant information
Name
Sedigheh Moghasemi
Name of organization / entity
Golestan university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0354
Email address
moghassemi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral Vitamin D3 supplementation on cardiovascular risk factors in post-menopausal women in Gorgan
Public title
The effect of Vitamin D supplementation on serum cardiovascular biomarkers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Postmenopausal women; absent of any serious diagnosed illnesses such as cardiovascular; diabetus mellitus; taking medications such as anti-diabetes; anti-hypertensive and anti-lipidemic agents; hormone replacement therapy (HRT); vitamin D and or calcium –D supplementation and smoking.
Exclusion criteria: using any medication which affect the outcome variables.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences
City
Gorgan
Postal code
49165-568
Approval date
2009-09-27, 1388/07/05
Ethics committee reference number
2135/35/پ/گ
Health conditions studied
1
Description of health condition studied
Cardiovascular
ICD-10 code
Y52.6
ICD-10 code description
Antihyperlipidaemic and antiarteriosclerotic drugs
Primary outcomes
1
Description
HDL
Timepoint
At baseline and after 12 weeks
Method of measurement
Serum
2
Description
Cholestrol
Timepoint
At baseline and after 12 weeks
Method of measurement
Serum
3
Description
LDL
Timepoint
At baseline and after 12 weeks
Method of measurement
Serum
4
Description
Triglyceride
Timepoint
At baseline and after 12 weeks
Method of measurement
serum
5
Description
FBS
Timepoint
At baseline and after 12 weeks
Method of measurement
Serum
6
Description
Blood Pressure
Timepoint
At baseline and after 12 weeks
Method of measurement
Serum
Secondary outcomes
empty
Intervention groups
1
Description
Oral pear of Vitamin D3 2000 IU daily for 12 weeks
Category
Treatment - Drugs
2
Description
Oral pearl placebo once daily for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in Gorgan
Full name of responsible person
Moghassemi Sedigheh
Street address
Golestan University of Medical Sciences
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University Of Medical Sciences
Full name of responsible person
Dr Golalipoor MJ
Street address
Golestan University of Medical Sciences
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
Golestan University of medical sciences
Full name of responsible person
Moghassemi Sedigheh
Position
MSc of Midwifery/ faculty member
Other areas of specialty/work
Street address
Golestan University of medical sciences
City
Gorgan
Postal code
49165568
Phone
+1 714430351
Fax
Email
moghasemi.s@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical sciences
Full name of responsible person
Moghassemi Sedigheh
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Golestan University of Medical sciences
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0351
Fax
Email
moghasemi.s@gmail.commoghassemi@goums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golesatn University of Medical sciences
Full name of responsible person
Moghassemi Sedigheh
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Golesatn University of Medical sciences
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0351
Fax
Email
Moghasemi.S@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)