Vitamin D Receptor Polymorphisms and Efficacy of Vitamin D-Fortified Yogurt Drink in Patients With Type 2 Diabetes
Determination of VDR Single Nucleotide Polymorphisms (SNPs ) and Their Rols in Efficacy of Vitamin D-fortified Yogurt Drink on the Metabolic-, Inflammatory - and Oxidative Stress Parameters in Type 2 Diabetic Patients
1 other identifier
interventional
180
1 country
4
Brief Summary
Study is a 12-week Double blind,controlled experiments designed to examine the possible effects of vitamin D receptor gene polymorphisms on the metabolic, inflammatory and oxidative stress markers in type 2 diabetic patients to vitamin D-fortified yogurt drink intake.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Oct 2009
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 9, 2010
CompletedFirst Posted
Study publicly available on registry
November 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedApril 26, 2012
April 1, 2012
1.4 years
August 9, 2010
April 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum 25-hydroxyvitamin D
3 months
Secondary Outcomes (5)
Glycemic control
3 Months
Inflammatory markers
3 Months
Oxidative stress markers
3 Months
Lipid profiles
3 Months
Blood pressure
3 Months
Study Arms (4)
Plain Yogurt Drink
PLACEBO COMPARATORDaily intake of unfortified yogurt drink(500 ml) for 12 weeks
VDR Genotype (aa)
EXPERIMENTALDaily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
VDR Genotype (AA)
EXPERIMENTALDaily intake of yogurt drink fortified (500 ml) with 1000 IU vitamin D for 12 weeks
VDR genotype (Aa)
EXPERIMENTALDaily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
Interventions
Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
Daily intake of unfortified yogurt drink(500 ml)for 12 weeks
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- Informed consent
- BMI between 25 to 35 kg/m2
- Age: 30-45 years old
- Willingness to maintain current body weight for the duration of the study
- Willingness to maintain baseline lifestyle activities and routines for the duration of the study
- Willingness to avoid the use of all over-the-counter or prescription vitamins, dietary supplements, and herbal products during the study
You may not qualify if:
- History of cardiovascular , Gastrointestinal , Renal disease and any other endocrinological disorders
- Subjects receiving vitamin D or omega-3 supplement
- Pregnancy , or lactation within the study period
- Treatment with insulin
- Treatment for weight reduction
- Treatment for reducing serum lipids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tirang R. Neyestanilead
- Tehran University of Medical Sciencescollaborator
Study Sites (4)
National Nutrition and Food Technology Research Institute
Tehran, Tehran Province, 19395-4741, Iran
National Nutrition and Food Technology Research Institute
Tehran, Tehran Province, 1981619573, Iran
Tirang Neyestani
Tehran, Tehran Province, Iran
Unknown Facility
Tehran, Iran
Related Publications (4)
Neyestani TR, Djazayery A, Shab-Bidar S, Eshraghian MR, Kalayi A, Shariatzadeh N, Khalaji N, Zahedirad M, Gharavi A, Houshiarrad A, Chamari M, Asadzadeh S. Vitamin D Receptor Fok-I polymorphism modulates diabetic host response to vitamin D intake: need for a nutrigenetic approach. Diabetes Care. 2013 Mar;36(3):550-6. doi: 10.2337/dc12-0919. Epub 2012 Nov 16.
PMID: 23160722DERIVEDShab-Bidar S, Neyestani TR, Djazayery A, Eshraghian MR, Houshiarrad A, Kalayi A, Shariatzadeh N, Khalaji N, Gharavi A. Improvement of vitamin D status resulted in amelioration of biomarkers of systemic inflammation in the subjects with type 2 diabetes. Diabetes Metab Res Rev. 2012 Jul;28(5):424-30. doi: 10.1002/dmrr.2290. Epub 2012 Feb 17.
PMID: 22344966DERIVEDShab-Bidar S, Neyestani TR, Djazayery A, Eshraghian MR, Houshiarrad A, Gharavi A, Kalayi A, Shariatzadeh N, Zahedirad M, Khalaji N, Haidari H. Regular consumption of vitamin D-fortified yogurt drink (Doogh) improved endothelial biomarkers in subjects with type 2 diabetes: a randomized double-blind clinical trial. BMC Med. 2011 Nov 24;9:125. doi: 10.1186/1741-7015-9-125.
PMID: 22114787DERIVEDShab-Bidar S, Neyestani TR, Djazayery A. Efficacy of vitamin D3-fortified-yogurt drink on anthropometric, metabolic, inflammatory and oxidative stress biomarkers according to vitamin D receptor gene polymorphisms in type 2 diabetic patients: a study protocol for a randomized controlled clinical trial. BMC Endocr Disord. 2011 Jun 22;11:12. doi: 10.1186/1472-6823-11-12.
PMID: 21696575DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tirang R. Neyestani, Ph.D.
National Nutrition & Food technology Research institute, P.O. Box 19395-4741
- STUDY CHAIR
Abolghasem Djazayeri, Professor
Tehran University of Medical Sciences
- PRINCIPAL INVESTIGATOR
Sakineh Shab-Bidar, M.Sc.
Tehran University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
August 9, 2010
First Posted
November 9, 2010
Study Start
October 1, 2009
Primary Completion
March 1, 2011
Study Completion
April 1, 2011
Last Updated
April 26, 2012
Record last verified: 2012-04