The aim of this study is to evaluate the effect of vitamin D injection on Endothelial Biomarkers, hs-CRP and blood pressure in vitamin D deficient patients with Type 2 Diabeties.
Design
controlled clinical trial with a parallel group
Settings and conduct
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.This study is done at the Yazd Diabetes Center.
Participants/Inclusion and exclusion criteria
Patients with type 2 diabetes with vitamin D deficiency
Intervention groups
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.
Main outcome variables
Improve vitamin D levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171003036539N2
Registration date:2019-09-15, 1398/06/24
Registration timing:retrospective
Last update:2019-09-15, 1398/06/24
Update count:0
Registration date
2019-09-15, 1398/06/24
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
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D injection on Endothelial Biomarkers, hs-CRP and blood pressure in vitamin D deficient patients with Type 2 Diabeties
Public title
The effect of vitamin D supplements on the treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes mellitus patients and HbA1c hemoglobin less than 9
levels of hydroxyvitamin D (25 OHD) less than 20 ng / ml
Age range 30-60 years
Exclusion criteria:
Use of vitamin D supplementation over the past 3 months-
Kidney,liver disease,Malabsorption syndrome,Severe infection
Pregnancy and lactation
Use of insulin
Age
From 30 years old to 70 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
50people who have been admitted to the study, who had been previously visited by the doctor,using random codes from the computer (random allocation table), participants were classified into two groups (each group number꞊ 25) . Randomization was performed by computer-generated and using random location software. The number 1 through 50 were assigned in the intervention and control groups. The first person was given number one and the last was given number 50.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
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
Province
Yazd
Postal code
8915173160
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.SSU.SPH.REC.1396.173
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
p-selectin of serum
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
ELISA method
Secondary outcomes
1
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
2
Description
Vitamin D of serum
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
ELISA method
3
Description
Systolic blood pressure
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Mercury barometer
4
Description
Diastolic blood pressure
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Mercury barometer
5
Description
wight
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
scales
6
Description
Serum Calcium
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Enzymatic method
7
Description
serum Phosphorus
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Enzymatic method
8
Description
Intercellular Adhesion Molecule-1 of serum
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
ELISA method
9
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
10
Description
Beck Depression score
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Beck Depression Inventory2 score
11
Description
Serum fasting blood sugar(FBS)
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Enzymatic method
12
Description
Serum triglyceride level (TG)
Timepoint
Before the intervention and two months after the start of the study
Method of measurement
Enzymatic method
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: 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
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9143
Fax
+98 35 3820 9119
Email
f.mirzavandi@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Hassan Mozaffari Khosravi
Street address
Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9143
Email
f.mirzavandi@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
farhang Mirzavandi
Position
MSc student of Health Sciences in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 353538209143
Email
f.mirzavandi@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr hassan mozaffari-khosravi
Position
PhD in Nutrition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 353538209143
Email
mozaffari.kh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
farhang Mirzavandi
Position
MSc student of Health Sciences in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 353538209143
Email
f.mirzavandi@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD