Determination of the effect of vitamin D-fortified milk on serum vitamin D, glycemic control, lipid profile, anthropometric measurements, and blood pressure in people with type 2 diabetes
The purpose of this study is determination the effect the effect of vitamin D-fortified milk on serum vitamin D, glycemic control, lipid profile, anthropometric measurements, and blood pressure in people with type 2 diabetes.
Inclusion criteria: type 2 diabetes; without insulin therapy; without calcium and vitamin D supplementation in the last 3 months; not having liver and kidney failure; not having malabsorption of fat (fatty diarrhea); Not taking medications that affect vitamin D metabolism; lack of blood triglyceride lowering drugs; not having difficulty in eating 1 cup of milk per day.
Exclusion criteria: Change the dose of glucose-lowering drugs; taking Calcium and vitamin D supplements during the study; Loss of more than 2 cups of milk a week , insulin therapy.
The study population are patients with type 2 diabetes and the sample size is 102 persons.
The study is Double blind and Blindness will be done in patients and researchers groups.
Participants will randomly classify into two groups. The intervention and control groups has a cup of low fat milk fortified with vitamin D and a cup of low fat milk daily, respectively. During the intervening period is 9 weeks. In this period, dietary intakes will be check by 24-hours recall and dietary record.
Before and after the intervention, blood sample will be taken to assess the changes (lipid profile and glycemic status , serum vitamin D, calcium and insulin levels).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021721120N1
Registration date:2015-05-10, 1394/02/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-10, 1394/02/20
Registrant information
Name
Saede Salehi
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 0579
Email address
stud2110014512@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shiraz University of Medical Science
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the effect of vitamin D-fortified milk on serum vitamin D, glycemic control, lipid profile, anthropometric measurements, and blood pressure in people with type 2 diabetes
Public title
The effect of vitamin D-fortified milk on diabetes control
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:type 2 diabetes; Maximum age 75 years; without insulin therapy; without calcium and vitamin D supplementation in the last 3 months; not having liver and kidney failure; not having malabsorption of fat (fatty diarrhea); no history of CVD; Not taking medications that affect vitamin D metabolism, such as PTH, estrogen and calcitonin; lack of blood triglyceride lowering drugs; light to moderate physical activity; not having difficulty in eating 1 cup of milk per day; Willingness to cooperate.
Exclusion criteria: Unwillingness to cooperate; Change the dose of glucose-lowering drugs; taking Calcium and vitamin D supplements during the study; Changes in levels of physical activity; Failure to adhere to the recommendations on diet and physical activity; Loss of more than 2 cups of milk a week; insulin therapy
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
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 Siraz University of Medical Science
Street address
Central Building of Shiraz University of Medical Sciences, Zand Ave. , Shiraz
City
Shiraz
Postal code
Approval date
2015-02-04, 1393/11/15
Ethics committee reference number
CT-9370-7350
Health conditions studied
1
Description of health condition studied
Dabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
fasting blood sugar
Timepoint
before intervention and after intervention
Method of measurement
blood test
Secondary outcomes
1
Description
Total cholestrol
Timepoint
before intervention, afer intervention
Method of measurement
blood test
2
Description
LDL cholestrol
Timepoint
before intervention, afer intervention
Method of measurement
blood test
3
Description
HDL cholestrol
Timepoint
before intervention, afer intervention
Method of measurement
blood test
4
Description
triglyceride
Timepoint
before intervention, afer intervention
Method of measurement
blood test
5
Description
serum calcium
Timepoint
before intervention, afer intervention
Method of measurement
blood test
6
Description
serum vitamin D
Timepoint
before intervention, afer intervention
Method of measurement
blood test
7
Description
serum insulin
Timepoint
before intervention, afer intervention
Method of measurement
blood test
8
Description
blood pressure
Timepoint
before intervention, 4 week after start of intervention, end of intervention
Method of measurement
mercury manometer
9
Description
weight
Timepoint
before intervention, 4 week after start of intervention, end of intervention
Method of measurement
digital scale
10
Description
waist circumference
Timepoint
before intervention, 4 week after start of intervention, end of intervention
Method of measurement
meter
11
Description
hip circumference
Timepoint
before intervention, 4 week after start of intervention, end of intervention
Method of measurement
meter
Intervention groups
1
Description
Intervention group: vitamin D-fortified low fat milk, 1 cup per day for 9 week
Category
Treatment - Other
2
Description
Control group: low fat milk, 1 cup per day for 9 week
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahmad Nader kazemi clinic
Full name of responsible person
Street address
Valiasr square - Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Science
Full name of responsible person
Dr Mohamad hadi Imanie
Street address
Central Building of Shiraz University of Medical Science , Zand Ave. , Shiraz
City
shiraz
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 of Shiraz University of Medical Science
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
Shiraz University of Medical Science
Full name of responsible person
Dr Masoume Akhlaghi
Position
Faculty member
Other areas of specialty/work
Street address
Faculty of Food Science and Nutrition, Razi Blvd, Shiraz
City
shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
msm.akhlaghi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr Masoume Akhlaghi
Position
faculty member
Other areas of specialty/work
Street address
Faculty of Food Science and Nutrition, Razi Blvd, Shiraz
City
shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
msm.akhlaghi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Saede Salahi
Position
Postgraduate student
Other areas of specialty/work
Street address
Faculty of Food Science and Nutrition, Razi Blvd, Shiraz
City
shiraz
Postal code
Phone
00
Fax
Email
salehi.saedeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)