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

April 25, 2012 updated by: Tirang R. Neyestani

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 19395-4741
        • 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
        • Tirang Neyestani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • FYD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum 25-hydroxyvitamin D
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Glycemic control
Time Frame: 3 Months
3 Months
Inflammatory markers
Time Frame: 3 Months
3 Months
Oxidative stress markers
Time Frame: 3 Months
3 Months
Lipid profiles
Time Frame: 3 Months
3 Months
Blood pressure
Time Frame: 3 Months
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tirang R. Neyestani

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Estimate)

April 26, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-1236-RV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Plain Yogurt Drink

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe