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

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 |
- serum 25-hydroxyvitamin D [ Time Frame: 3 months ]
- 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 ]

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Ages Eligible for Study: | 30 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
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 |
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 |
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 |
Vitamin D fortification Yogurt Drink Efficacy |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |