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

This study has been completed.
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Tirang R. Neyestani, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:
NCT01236846
First received: August 9, 2010
Last updated: April 25, 2012
Last verified: April 2012
History of Changes

August 9, 2010
April 25, 2012
October 2009
March 2011   (final data collection date for primary outcome measure)
serum 25-hydroxyvitamin D [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01236846 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Type 2 Diabetes Mellitus
  • Dietary Supplement: Fortified Yogurt Drink
    Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
    Other Name: FYD
  • Dietary Supplement: Plain Yogurt Drink
    Daily intake of unfortified yogurt drink(500 ml)for 12 weeks
    Other Name: PYD
  • Placebo Comparator: Plain Yogurt Drink
    Daily intake of unfortified yogurt drink(500 ml) for 12 weeks
    Intervention: Dietary Supplement: Plain Yogurt Drink
  • Experimental: VDR Genotype (aa)
    Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
    Intervention: Dietary Supplement: Fortified Yogurt Drink
  • Experimental: VDR Genotype (AA)
    Daily intake of yogurt drink fortified (500 ml) with 1000 IU vitamin D for 12 weeks
    Intervention: Dietary Supplement: Fortified Yogurt Drink
  • Experimental: VDR genotype (Aa)
    Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
    Intervention: Dietary Supplement: Fortified Yogurt Drink

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
April 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
30 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01236846
ABT-1236-RV
Yes
Tirang R. Neyestani, National Nutrition and Food Technology Institute
Tirang R. Neyestani
Tehran University of Medical Sciences
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
National Nutrition and Food Technology Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP