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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Fortified Yogurt Drink Dietary Supplement: Plain Yogurt Drink Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. serum 25-hydroxyvitamin D [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Glycemic control [ Time Frame: 3 Months ]
  2. Inflammatory markers [ Time Frame: 3 Months ]
  3. Oxidative stress markers [ Time Frame: 3 Months ]
  4. Lipid profiles [ Time Frame: 3 Months ]
  5. Blood pressure [ Time Frame: 3 Months ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236846


Locations
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Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute
Tehran, Iran, Islamic Republic of, 19395-4741
National Nutrition and Food Technology Research Institute
Tehran, Iran, Islamic Republic of, 1981619573
Tirang Neyestani
Tehran, Iran, Islamic Republic of
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tirang R. Neyestani
Tehran University of Medical Sciences
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tirang R. Neyestani, associate professor, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT01236846    
Other Study ID Numbers: ABT-1236-RV
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: April 26, 2012
Last Verified: April 2012
Keywords provided by Tirang R. Neyestani, National Nutrition and Food Technology Institute:
Vitamin D fortification
Yogurt Drink
Efficacy
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases