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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01236846

Enrollment

180

Registered

2010-11-09

Start date

2009-10-31

Completion date

2011-04-30

Last updated

2012-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Vitamin D fortification, Yogurt Drink, Efficacy

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.

Interventions

DIETARY_SUPPLEMENTFortified Yogurt Drink

Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks

DIETARY_SUPPLEMENTPlain Yogurt Drink

Daily intake of unfortified yogurt drink(500 ml)for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
serum 25-hydroxyvitamin D	3 months

Secondary

Measure	Time frame
Blood pressure	3 Months
Glycemic control	3 Months
Inflammatory markers	3 Months
Oxidative stress markers	3 Months
Lipid profiles	3 Months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026