Studies show that low vitamin D and Adiponectin levels are common in diabetic patients. In addition, low levels of vitamin D and Adiponectin are associated with increased cardiovascular disease risk and that low vitamin D levels may increase insulin resistance. The main purpose of this study is to see whether vitamin D supplementation can improve insulin resistance and Adiponectin levels in patients with Diabetes Mellitus type2. The randomized, placebo-controlled, double-blind clinical trial will be conducted at the Endocrinology and Metabolism Research Institute of Tehran University of Medical Sciences, Tehran, Iran. All patients seen in the institute clinics with vitamin D level between 10-30 ng/ml and do not have any of the exclusion criteria will be eligible for recruitment in the study. The study participants will be randomly assigned into 2 groups for intervention to receive oral vitamin D in 50000IU or placebo per week for 8 weeks as per group allocation. Each group will comprise of 40 participants. Vitamin D levels, insulin resistance and Adiponectin levels along with the other biochemical and nutritional parameter will be measured before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052111421N2
Registration date:2013-06-12, 1392/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-12, 1392/03/22
Registrant information
Name
Kurosh Djafarian
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 88973901
Email address
kdjafarian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of Medical Sciences
Expected recruitment start date
2013-02-01, 1391/11/13
Expected recruitment end date
2013-07-01, 1392/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of Vitamin D supplementation on insulin resistance and Adiponectin levels in patients with Diabetes Mellitus type 2
Public title
Effect of vitamin D supplementation on diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
- personal tendency to take part in the study
- DM II which has been diagnosed at least one year ago or before
- The onset of diabetes should be at age 30 or older.
- BMI between 25 to 30 Kg/ M2
- Age: 31 to 65 years old
- 25(OH) VitD serum levels between 10-30 ng/ml
- Hb A1c < 8%
- no history of smoking
- no history of alcohol
- no history of treatment with insulin
- no monopose/ no pregnancy
- no history of using agents interacting vit D like: corticosteroids, anti-epileptics and OCP in last 6 month
- no history of using supplementary calcium and VitD in last 6 month
- no history of angina pectoris, MI & CVA in last 12 months
- no history of liver and kidney disease, chronic inflammatory diseases or thyroid diseases.
- no history of treatment with thiasolidindions
-failing to use prescribed supplemetary agent on the regular program
-any change in diet during the study
-any change in dose and type of prescribed medication during study
-lack of tendency to complete the study
-any history of sckeletal pain and fracture
Age
From 31 years old to 65 years old
Gender
Both
Phase
1
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
Endocrinology and Metabolism Research Institute of Tehran University of Medical Sciences
Street address
shariati hospital,kargar st
City
TEHRAN
Postal code
1411413137
Approval date
2013-04-17, 1392/01/28
Ethics committee reference number
EC:00
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
adiponectin
Timepoint
before and after intervention
Method of measurement
kit
2
Description
insulin resistance
Timepoint
before and after intervention
Method of measurement
Calculation
Secondary outcomes
1
Description
BMI
Timepoint
before and after intervention
Method of measurement
Calculation based on weigh and height
Intervention groups
1
Description
Intervention supplement of 50000IU vitamin d3 per week for 8weeks
Category
Treatment - Drugs
2
Description
control:edible parafin oil as pelacebo weekly for 8weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Institute of Tehran University of Medical Sciences
Full name of responsible person
Mr. Baziar
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Institute of Tehran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research
Street address
5th floor,shariati hospital
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Institute of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Kurosh Djafarian
Position
Academic staff
Other areas of specialty/work
Street address
School of Nutrition Sciences and Dietetic
City
Tehran
Postal code
Phone
00
Fax
Email
kdjafarian@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mr Baziar
Position
Msc Student
Other areas of specialty/work
Street address
School of nutrition Sciences and Dietetic
City
Tehran
Postal code
Phone
00
Fax
Email
nima.baziar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Kurosh Djafarian
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)