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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Plain Yogurt Drink; Dietary Supplement: Fortified Yogurt Drink

• Registration Number: NCT01236846
• Lead Sponsor: Tirang R. Neyestani

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-25
• Last Update Posted: 2012-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plain Yogurt Drink	Plain Yogurt Drink	Daily intake of unfortified yogurt drink(500 ml) for 12 weeks
VDR Genotype (AA)	Fortified Yogurt Drink	Daily intake of yogurt drink fortified (500 ml) with 1000 IU vitamin D for 12 weeks
VDR Genotype (aa)	Fortified Yogurt Drink	Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
VDR genotype (Aa)	Fortified Yogurt Drink	Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks

Primary Outcome Measures

Name	Time	Method
serum 25-hydroxyvitamin D	3 months

Secondary Outcome Measures

Name	Time	Method
Oxidative stress markers	3 Months
Lipid profiles	3 Months
Glycemic control	3 Months
Inflammatory markers	3 Months
Blood pressure	3 Months

Trial Locations

Locations (2)

Tirang Neyestani; 🇮🇷 Tehran, Iran, Islamic Republic of

National Nutrition and Food Technology Research Institute; 🇮🇷 Tehran, Iran, Islamic Republic of