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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236846
• Other study ID #: ABT-1236-RV
• Status: Completed
• Phase: N/A
• First received: August 9, 2010
• Last updated: April 25, 2012
• Start date: October 2009
• Est. completion date: April 2011

Study information

• Verified date: April 2012
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Fortified Yogurt Drink
Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
• Plain Yogurt Drink
Daily intake of unfortified yogurt drink(500 ml)for 12 weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran
Iran, Islamic Republic of	Tirang Neyestani	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tirang R. Neyestani	Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25-hydroxyvitamin D		3 months	Yes
Secondary	Glycemic control		3 Months	Yes
Secondary	Inflammatory markers		3 Months	Yes
Secondary	Oxidative stress markers		3 Months	Yes
Secondary	Lipid profiles		3 Months	Yes
Secondary	Blood pressure		3 Months	Yes