The aim of this study is to evaluate the possible effects of vitamin D supplementation on carotid intima-media thickness and risk factors of cardiovascular disease in patients with metabolic syndrome. To do this, 80 volunteers with metabolic syndrome and with the age of 30-50 years will be studied. This study will be double blinded (subjects and researchers).Subjects will be selected and assigned randomly to one of the two groups; intervention: 50000 IU vitamin D3 and placebo. Participants will be asked to take one supplement every week with lunch for 4 months. Dietary intake, exposure on sunlight, physical activity will be assessed in baseline, after2 months and at the end of the study. At the first and last visits, carotid intima media thickness and inflammatory and metabolic factors, insulin, 25-OHD , parathyroid hormone and calcium will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409033140N14
Registration date:2014-10-27, 1393/08/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-27, 1393/08/05
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Tabriz University of Medical Science
Expected recruitment start date
2014-11-07, 1393/08/16
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on carotid intima-media thickness and risk factors of cardiovascular disease in patients with metabolic syndrome
Public title
vitamin D supplementation in metabolic syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate; age 30–50 years; affected by metabolic syndrome with three out of five criteria: waist circumference>91 cm in women and >89 cm for men; serum triglyceride≥150 mg/dL; fasting serum glucose≥100mg/dL; serum HDL-C<40 mg/dL in men and <50 mg/dl in women; systolic blood pressure≥130mmhg and/or diastolic blood pressure≥ 85mmhg. Exclusion criteria: being menopause; taking vitamin D, calcium, fish oil or other antioxidant supplements for at least 3 months preceding the study; taking anti lipid or anti-hypertensive drugs; smoking; current clinical disease like diabetes mellitus; cardiovascular disease; cancers; liver or kidney disease; any symptoms of inflammation or having surgery; parathyroid abnormalities; using corticosteroids, calcitonin, bisphosphonates for at least 3 months preceding the study; spiro or crohn disease; current diet therapy; pregnancy or lactation.
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
َAttar Neyshaboori Street, Golgasht street, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2014-08-01, 1393/05/10
Ethics committee reference number
93100
Health conditions studied
1
Description of health condition studied
metabolic syndrome
ICD-10 code
ٍE88.9
ICD-10 code description
metabolic disorders not specified
Primary outcomes
1
Description
serum 25-hydroxyvitamin vitamin D
Timepoint
befor and after intervention
Method of measurement
chemiluminescence immunoassay
2
Description
carotid intima media thickness
Timepoint
baseline and 4 months after intervention
Method of measurement
ultrasonography
Secondary outcomes
1
Description
serum inflammatory markers
Timepoint
baseline and 4 months after intervation
Method of measurement
ELISA
2
Description
Glycemic factors
Timepoint
baseline and 4 months after intervation
Method of measurement
enzymatic
3
Description
Lipid profiles
Timepoint
baseline and 4 months after intervation
Method of measurement
enzymatic colorimetric
4
Description
Blood pressure
Timepoint
baseline, 2 and 4 months after intervation
Method of measurement
digital sphygmomanometer
5
Description
anthropometry markers
Timepoint
baseline , 2 and 4 months after intervation
Method of measurement
tape, scale, impedance analysis
Intervention groups
1
Description
Intervention: 50000 IU vitamin D3 every week for 4 months
Category
Prevention
2
Description
Control group: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Nutrition, Tabriz University of Medical Sceinces
Full name of responsible person
Dr. Pourgasem Gargari
Street address
Golgasht Ave, Attar Neyshaboori St, Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Attar Neyshaboori St, Golgasht Ave, Tabriz University of Medical Sciences
City
Tabriz
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, Tabriz 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
Faculty of Nutrition, Tabriz University pf Medical Sciences
Full name of responsible person
Shabnam Salekzamani
Position
Ph.D candidate of Nutrition
Other areas of specialty/work
Street address
Attar Neyshaboori St, Golgasht Ave, Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7580
Fax
Email
salekzamanish@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bahram Pourghasem Gargari
Position
Ph.D of Nutrition
Other areas of specialty/work
Street address
Attar Neyshaboori St, Golgasht Ave, Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7580
Fax
Email
bahrampg@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Shabnam Salekzamani
Position
Ph.D candidate of Nutrition
Other areas of specialty/work
Street address
Golgasht Ave, Attar Neyshaboori St, Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3335 7580
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)