Comparison of efficacy of vitamin D and vitamin D-calcium fortified dough on glycemic, metabolic, inflammatory, immunity and oxidative stress markers in type 2 diabetes.
The aim of this study is to evaluate the possible effects of daily intake of yogurt drink fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic, metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM). To do this, 90 diabetic patients will be selected. Patients who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Patients will be assigned randomly to one of the three intervention groups. 1. Plain yogurt drink 2. Vitamin D-fortified yogurt drink 3. Vitamin D-calcium fortified yogurt drink. Each patient will consume 2 servings of yogurt drink every day for 3 months with lunch and dinner. At the first and last visits, dietary and laboratory assessments will be performed for all patients. Primary outcomes are improvement in glycemic, inflammatory and immunity markers and secondary outcome is prevention of long-term diabetic complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810163006N1
Registration date:2010-02-26, 1388/12/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-02-26, 1388/12/07
Registrant information
Name
Tirang Reza Neyestani
Name of organization / entity
National nutrition and food technology research institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 6471
Email address
t.neyestani@nnftri.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and food Technology Research institute, Shahid Beheshti University of Medical Sciences & Health Services
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of vitamin D and vitamin D-calcium fortified dough on glycemic, metabolic, inflammatory, immunity and oxidative stress markers in type 2 diabetes.
Public title
Fortified dough and diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age: 30 to 50 years, Fasting blood glucose ≥ 126 mg/dl.
Exclusion criteria: Receiving vitamin D or calcium or omega-3 supplements within the last three months, On any medication which could potentially influence vitamin D metabolism (notably estrogens, and calcitonin) within the last three months, Any other concomitant disease such as renal, hepatic, and other endocrinological disorders, and malignancies, which could influence vitamin D metabolism. Receiving insulin or any change in the type and/or dose of the current hypoglycemic medications
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and food Technology Research institute, Shahid Beheshti University of Medical Sci
Street address
West Arghavan St., Farahzadi Blvd., Shahrak Qods,
City
Tehran
Postal code
1981619573
Approval date
2010-01-05, 1388/10/15
Ethics committee reference number
034356
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E 11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
improvement of Vitamin D status
Timepoint
baseline and 3 month after intervention
Method of measurement
serum level of 25OHD
Secondary outcomes
1
Description
improvement of inflammation and immunity markers
Timepoint
Baseline and 3 month after intervention
Method of measurement
serum CRP, IL-6, IgM, IgG, MPO and IL-1β، IFN-γ و TNF-α concentrations in PBMCs culture medium
2
Description
improvement of oxidate stress markers
Timepoint
baseline and 3 month after intervention
Method of measurement
total anti-oxidant capacity [TAC], carbonyl protein, MDA
3
Description
improvement of bone markers
Timepoint
baseline and 3 month after intervention
Method of measurement
serum calcium, phosphor, magnesium, PTH, osteocalcin and osteopontin
Intervention groups
1
Description
interventiona group 1: fortified doogh with 500 IU cholecalciferol per 250 mL
Category
Treatment - Other
2
Description
control group: plain doogh
Category
empty
3
Description
interventional group 2: fortified doogh with 500IU cholecalciferol and 250mg calcium per 250 mL
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
National nutrition and food technology research institute
Full name of responsible person
Dr Neyestani
Street address
West Arghavan St., Farahzadi Blvd., Shahrak Qods,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and food Technology Research institute, Shahid Beheshti University of Medical Sci
Full name of responsible person
Dr Mohammad Hossein Azizi
Street address
West Arghavan St., farahzadi Blvd., Shahrak Qods
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and food Technology Research institute, Shahid Beheshti University of Medical Sci
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
National Nutrition and food Technology Research institute, Shahid Beheshti University of Medical Sci