In this study military individuals who their waist circumference is greater than or equal to 80 cm (for women) and greater than or equal to 94 cm (for men) will be referred to the laboratory to measure vitamin D and other factors necessary for the diagnosis of metabolic syndrome . Blood samples were collected in the laboratory to evaluate the lipid profiles and blood sugar . Blood pressure (average 2 seated blood pressure measurements)and vitamin D concentration were also measured.After evaluating of laboratory results, those with metabolic syndrome according to IDF criteria and also have vitamin D deficiency (serum 25-hydroxyvitamin D less than 20 ng ml) have been included, and base on exclusion criteria, will be selected. Then, based on a randomized block design will be assigned to intervention and control groups. Intervention group will receive vitamin D Pearl with dose of 50000IU once a week for 8 weeks, and control group will receive placebo one pearl weekly. After the intervention period , all the above mentioned measurements are performed again to evaluate the changes.Blinding to both patients and for researcher will be conducted.,Manufacture will offer vitamin D and placebo pearl as code A and B quite similar in appearance. neither patient nor researcher having information about pearl.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020211920N3
Registration date:2015-01-09, 1393/10/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-09, 1393/10/19
Registrant information
Name
Sepideh Abbaszadeh
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 0153
Email address
abbaszadehs@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Baqiyatallah University of Medical Sciences.
Expected recruitment start date
2014-12-11, 1393/09/20
Expected recruitment end date
2015-03-16, 1393/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on metabolic syndrome Components in Military with metabolic syndrome
Public title
Effect of Vitamin D on metabolic syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : military staff ; Metabolic Syndrome; vitamin D deficiency exclusion criteria: Diabetes ;Thyroid disorders ;Liver disease
;Kidney disease; Pregnancy and lactation ;Developing chronic steatorrhea
;Cholecystectomy ; consumption vitamin D supplementation
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
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 Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Molla Sadra street , Sheikh Bahaei street, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-07-31, 1393/05/09
Ethics committee reference number
93/754ج
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
2
Description of health condition studied
metabiloc syndrome
ICD-10 code
E78.8
ICD-10 code description
Other disorders of lipoprotein metabolism
3
Description of health condition studied
vitamin D deficiency
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified
Primary outcomes
1
Description
Triglycerides
Timepoint
befor and after intervention
Method of measurement
Milligrams per deciliter / enzymatic method using a kit
2
Description
Fasting blood glucose
Timepoint
befor and after intervention
Method of measurement
Milligrams per deciliter / enzymatically
Secondary outcomes
1
Description
weight
Timepoint
befor and after intervention
Method of measurement
kg/Using a digital scale
2
Description
Length
Timepoint
befor and after intervention
Method of measurement
cm/using the meter
3
Description
Serum level of Vitamin D
Timepoint
Before and after the study
Method of measurement
Eliza
4
Description
Systolic blood pressure
Timepoint
Before and after the study
Method of measurement
Using a sphygmomanometer in the sitting position
5
Description
Dystolic blood pressure
Timepoint
befor and after study
Method of measurement
Using a sphygmomanometer in the sitting position
6
Description
High-density lipoprotein
Timepoint
befor and after study
Method of measurement
Calorimetry
7
Description
waist circumference
Timepoint
befor and after study
Method of measurement
Using a tape measure in between the last rib, chest and navel waist measured.
Intervention groups
1
Description
Vitamin D supplementation in single pearl 50000 at 1 pill per week for 8 weeks ,(Totaling 300,000 units)
Category
Treatment - Drugs
2
Description
Placebo with vitamin D look like pearls ,1 pill weekly for 8 weeks will be given
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fallahi Clinic
Full name of responsible person
Mohamad Amani
Street address
Department of Health and Relief Treatment Army, martyr clinic Fallahi, Lavizan, martyr Babaei Highway (East), Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellorof Baqiyatallah University of Medical Sciences.
Full name of responsible person
Mr hoseinishokooh
Street address
Baqiyatallah University of Medical Sciences, Molla Sadra street , Sheikh Bahaei street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellorof Baqiyatallah 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
Department of Health and Relief Therapy Army
Full name of responsible person
Mohammad Amani
Position
MSc in Nutrition
Other areas of specialty/work
Street address
Department of Health and Relief Therapy Army, input Lavizan, martyr Babaei Highway (East), Tehran
City
Tehran
Postal code
Phone
+98 21 2295 1539
Fax
+98 22951926
Email
mo_amani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
PhD student in nutrition
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Molla Sadra street , Sheikh Bahaei street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8248 2467
Fax
Email
parastouei@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Health and Relief Therapy Army
Full name of responsible person
Mohammad Amani
Position
MSc in nutrition
Other areas of specialty/work
Street address
Department of Health and Relief Therapy Army, input Lavizan, martyr Babaei Highway (East), Tehran
City
Tehran
Postal code
021
Phone
+98 21 2295 1539
Fax
Email
mo_amani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)