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

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ClinicalTrials.gov Identifier: NCT01236846
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : April 26, 2012
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Tirang R. Neyestani, National Nutrition and Food Technology Institute

Tracking Information
First Submitted Date  ICMJE August 9, 2010
First Posted Date  ICMJE November 9, 2010
Last Update Posted Date April 26, 2012
Study Start Date  ICMJE October 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2010)
serum 25-hydroxyvitamin D [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2010)
  • Glycemic control [ Time Frame: 3 Months ]
  • Inflammatory markers [ Time Frame: 3 Months ]
  • Oxidative stress markers [ Time Frame: 3 Months ]
  • Lipid profiles [ Time Frame: 3 Months ]
  • Blood pressure [ Time Frame: 3 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Receptor Polymorphisms and Efficacy of Vitamin D-Fortified Yogurt Drink in Patients With Type 2 Diabetes
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2012)
180
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2010)
120
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01236846
Other Study ID Numbers  ICMJE ABT-1236-RV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tirang R. Neyestani, National Nutrition and Food Technology Institute
Study Sponsor  ICMJE Tirang R. Neyestani
Collaborators  ICMJE Tehran University of Medical Sciences
Investigators  ICMJE
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
PRS Account National Nutrition and Food Technology Institute
Verification Date April 2012

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