Vitamin D Receptor Polymorphisms and Efficacy of Vitamin D-Fortified Yogurt Drink in Patients With Type 2 Diabetes - Full Text View

Purpose

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.

Condition	Intervention
Type 2 Diabetes Mellitus	Dietary Supplement: Fortified Yogurt Drink Dietary Supplement: Plain Yogurt Drink

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor)
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

Further study details as provided by National Nutrition and Food Technology Institute:

Primary Outcome Measures:

serum 25-hydroxyvitamin D [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Glycemic control [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
Inflammatory markers [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
Oxidative stress markers [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
Lipid profiles [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
Blood pressure [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Enrollment:	180
Study Start Date:	October 2009
Study Completion Date:	April 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Plain Yogurt Drink Daily intake of unfortified yogurt drink(500 ml) for 12 weeks	Dietary Supplement: Plain Yogurt Drink Daily intake of unfortified yogurt drink(500 ml)for 12 weeks Other Name: PYD
Experimental: VDR Genotype (aa) Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks	Dietary Supplement: Fortified Yogurt Drink Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks Other Name: FYD
Experimental: VDR Genotype (AA) Daily intake of yogurt drink fortified (500 ml) with 1000 IU vitamin D for 12 weeks	Dietary Supplement: Fortified Yogurt Drink Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks Other Name: FYD
Experimental: VDR genotype (Aa) Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks	Dietary Supplement: Fortified Yogurt Drink Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks Other Name: FYD

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

Ages Eligible for Study:	30 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236846

Locations

Iran, Islamic Republic of

Tehran, Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute
Tehran, Iran, Islamic Republic of, 1981619573
National Nutrition and Food Technology Research Institute
Tehran, Iran, Islamic Republic of, 19395-4741
Tirang Neyestani
Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Tirang R. Neyestani

Tehran University of Medical Sciences

Investigators

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

More Information

No publications provided by National Nutrition and Food Technology Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Neyestani TR, Djazayery A, Shab-Bidar S, Eshraghian MR, Kalayi A, Shariátzadeh 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.

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.

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.

Responsible Party:	Tirang R. Neyestani, associate professor, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:	NCT01236846 History of Changes
Other Study ID Numbers:	ABT-1236-RV
Study First Received:	August 9, 2010
Last Updated:	April 25, 2012
Health Authority:	Iran: Ministry of Health

Keywords provided by National Nutrition and Food Technology Institute:

Vitamin D fortification
Yogurt Drink
Efficacy

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin D
Ergocalciferols

Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013