Clinical trial NCT01236846: Vitamin D Receptor Polymorphisms and Efficacy of Vitamin D-Fortified Yogurt Drink in Patients With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Vitamin D fortification
Yogurt Drink
Efficacy
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
Collaborators: name: Tehran University of Medical Sciences
First posted: 2010-11-09
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: In a 12-week randomized controlled trial ( double-blind study), based on data on serum 25(OH)D changes from other studies (35), to achieve 1 standard deviation difference in circulating 25(OH)D with two-sided alpha of 0.05 and a beta of 0.2 after a 12-week intervention period, the sample size was calculated 40 individuals per treatment group. Considering 3 polymorphic variant groups and one control group which receives plain yogurt drink, 160 subjects are needed. Allowing for 10% attrition over 12 weeks of intervention, a total of 180 subjects are required. In treatment groups, all patients receive 500 ml per day of low-fat (1%) Yogurt Drink fortified with approximately 500IU of vitamin D3 . Control group receives 500 ml per day of plain (unfortified) Yogurt Drink. Metabolic, inflammatory and oxidative stress markers are evaluated at the beginning and in the end of the interventional period.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: serum 25-hydroxyvitamin D
timeFrame: 3 months
Secondary outcomes:
measure: Glycemic control
timeFrame: 3 Months
measure: Inflammatory markers
timeFrame: 3 Months
measure: Oxidative stress markers
timeFrame: 3 Months
measure: Lipid profiles
timeFrame: 3 Months
measure: Blood pressure
timeFrame: 3 Months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
city: Tehran
country: Iran, Islamic Republic of
facility: Tirang Neyestani
city: Tehran
country: Iran, Islamic Republic of
Study officials:
affiliation: National Nutrition & Food technology Research institute, P.O. Box 19395-4741
name: Tirang R. Neyestani, Ph.D.
role: STUDY_CHAIR
affiliation: Tehran University of Medical Sciences
name: Abolghasem Djazayeri, Professor
role: STUDY_CHAIR
affiliation: Tehran University of Medical Sciences
name: Sakineh Shab-Bidar, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Shab-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.
citation: Shab-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.
citation: Shab-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.