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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014