The effect of vitamin D injection on Endothelial Biomarker, hs-CRP, Lipid profile and Glycemic Control in vitamin D deficient patients with Type 2 Diabeties
This study is randomized,control, clinical trial.The aim of this study is to evaluate the effect of vitamin D injection on Endothelial Biomarker, hs-CRP, Lipid profile and Glycemic Control in vitamin D deficient patients with Type 2 Diabeties.Sample of the study includes 50 of Patients (25 patients in the Vitamin D group and 25 patients in the control group). The intervention group receives 200000IU Vitamin D injection at baseline and 4-weeks and one group had no treatment. Anthropometric and biochemical measurements, medical and general information and food records for each person will be collected at the beginning and end of the study.Duration of intervention will be 2 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100336539N1
Registration date:2017-11-08, 1396/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
farhang mirzavandi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences,Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 71 4331 1619
Email address
f.mirzavandi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences Yazd
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D injection on Endothelial Biomarker, hs-CRP, Lipid profile and Glycemic Control in vitamin D deficient patients with Type 2 Diabeties
Public title
The effect of vitamin D on the treatment of type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion: Diabetes mellitus patients and HbA1c hemoglobin less than 9 percent 2-25 levels of hydroxyvitamin D (25 OHD) less than 20 ng / ml 3- Age range 30-60 years
and Exclusion criteria:1 - Lack of interest in participating in the study-2-Use of vitamin D supplementation over the past 3 months-3-Kidney,liver disease,Malabsorption syndrome,Severe infection-4-Use of immunosuppressive drugs-5- Pregnancy and lactation- 6- Use of insulin
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences Yazd
Street address
Yazd - Alam Square - Anonymous Martyrs Blvd - Campus of Shahid Sadoughi University of Medical Sciences Yazd - Yazd School of Public Hea
City
Yazd
Postal code
8915173160
Approval date
2017-08-06, 1396/05/15
Ethics committee reference number
IR.SSU.SPH.REC.1396.89
Health conditions studied
1
Description of health condition studied
Type II diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
E-Selectin of serum
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
ELISA method
2
Description
high-sensitivity C-reactive protein (hs-CRP) of serum
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
ELISA method
3
Description
Serum fasting blood sugar(FBS)
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Enzymatic method
4
Description
Vitamin D of serum
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
ELISA method
5
Description
Serum total cholesterol
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Enzymatic method
6
Description
Serum triglyceride level (TG)
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Enzymatic method
7
Description
Serum high density lipoprotein cholesterol (HDL-C)
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Enzymatic method
8
Description
Serum low Density Lipoprotein cholesterol (LDL-C)
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Enzymatic method
9
Description
Serum Calcium
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Enzymatic method
10
Description
serum Phosphorus
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Enzymatic method
Secondary outcomes
1
Description
Weight
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
by body Calibrated scale
2
Description
Body mass index
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
by body Calibrated scale
3
Description
Body fat percent
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
by body Calibrated scale
4
Description
Muscle mass percent
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
by body Calibrated scale
5
Description
visceral fat percent
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
by body Calibrated scale
6
Description
evalution of patients diet
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Three-day food record
Intervention groups
1
Description
Intervention: injection of Vitamin D 400000 IU first and one month after the start of the study each time 200,000 IU
Duration of study 2 months.
The control group does not receive anything.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Fakhredin Shiranian
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd
Full name of responsible person
Dr. Hassan Mozaffari Khosravi
Street address
Yazd- Alam-Blvarchy Square, Anonymous-Campus, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences Yazd
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 Sadoughi University of Medical Sciences and Health Services Yazd
Full name of responsible person
FARHANG MIRZAVANDI
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Al
Postal code
8915173160
Phone
+98 35 3820 9143
Fax
+98 35 3820 9119
Email
f.mirzavandi@ssu.ac.ir farhangfm@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Dr hassan mozaffari-khosravi
Position
PhD in Nutrition Sciences
Other areas of specialty/work
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Postal code
8915173160
Phone
+98 353538209143
Fax
+98 35 3820 9119
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of nutrition, faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Ir
Full name of responsible person
farhang Mirzavandi
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
City
Yazd
Postal code
8915173160
Phone
+98 353538209143
Fax
+98 35 3820 9119
Email
f.mirzavandi@ssu.ac.irfarhangfm@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)