Effects of long-term vitamin D supplementation compared with the placebo on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease
Objective: The aim of this study is to determine the effects of long-term vitamin D supplementation on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease (CHD). Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Invituals aged 45-75 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 type 2 diabetes patients with CHD eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 50000 IU vitamin D supplements every two weeks (intervention group: n=30) or placebo (control group: n=30). CIMT will be determined at baseline and after 24-wk intervention. Fasting blood samples will be taken at baseline and after 24-wk intervention to measure metabolic profiles. Start and end date of intervention: 24 weeks. Outcomes: Fasting plasma glucose (FPG), serum insulin and lipid profiles will be measured at baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510315623N56
Registration date:2015-12-02, 1394/09/11
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2015-11-01, 1394/08/10
Expected recruitment end date
2015-11-11, 1394/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of long-term vitamin D supplementation compared with the placebo on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease
Public title
Effect of supplementation in treatment of Coronary Heart Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Subjects aged 45-75 years; diagnosed with type 2 diabetes and coronary heart disease.
Exclusion criteria: Unwillingness to cooperate.
Age
From 45 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences
City
Kashan
Postal code
Approval date
2015-10-28, 1394/08/06
Ethics committee reference number
IR.KAUMS.REC.1394.91
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Ischaemic heart disease (chronic) NOS
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Questionnaire
3
Description
Carotid intima media thickness
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Triglycerides
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Total cholesterol
Timepoint
At the beginning of the study and after 24 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Control group: Placebo capsule, every 2 weeks, for 24 weeks orally.
Category
Treatment - Drugs
2
Description
Intervention group: Vitamin D capsule, 50000 IU, every 2 weeks, for 24 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
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, Kashan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)