Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients

Type 2 Diabetes Clinical Trial

Official title:

Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink on Glycemic, Metabolic, Inflammatory, Immunity and Oxidative Stress Markers in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229891
• Other study ID #: 11024
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2010
• Last updated: December 10, 2011
• Start date: October 2009
• Est. completion date: September 2010

Study information

• Verified date: December 2011
• 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

The aim of this study is to evaluate the possible effects of daily intake of yogurt drink fortified with vitamin D alone or with vitamin D + calcium on some selected glycemic, metabolic, inflammatory and oxidative stress markers in patients with type 2 diabetes (T2DM).

Description:

ninety diabetic patients will be selected. Patients who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Patients will be assigned randomly to one of the three intervention groups. 1. Plain yogurt drink 2. Vitamin D-fortified yogurt drink 3. Vitamin D-calcium fortified yogurt drink. Each patient will consume 2 servings of yogurt drink every day for 3 months with lunch and dinner. At the first and last visits, dietary and laboratory assessments will be performed for all patients. Primary outcomes are improvement in glycemic, inflammatory and immunity markers and secondary outcome is prevention of long-term diabetic complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:Age:

• 30 to 50 years,

• Fasting blood glucose = 126 mg/dl

Exclusion Criteria:

• Receiving vitamin D or calcium or omega-3 supplements within the last three months,

• On any medication which could potentially influence vitamin D metabolism (notably estrogens, and calcitonin) within the last three months,

• Any other concomitant disease such as renal, hepatic, and other endocrinological disorders, and malignancies, which could influence vitamin D metabolism.

• Receiving insulin or any change in the type and/or dose of the current hypoglycemic medications

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• plain yogurt drink
daily intake of two bottle of plain yogurt drink
• vitamin D fortified yogurt drink
daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D/250 mL
• vitamin D-calcium yogurt drink
daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 ml package

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25-hydroxyvitamin D		12-week	Yes
Secondary	Fasting Serum Glucose (FSG)		12-week	Yes
Secondary	Insulin	fasting serum insulin concentration	12-week	Yes
Secondary	Hemoglobin A1c (HbA1c)		12-week	Yes
Secondary	Serum Triglyceride (TG)		12-week	Yes
Secondary	Serum Total Cholesterol (Tchol)		12-week	Yes
Secondary	Serum Low Density Lipoprotein (LDL)		12-week	Yes
Secondary	Serum High Density Lipoprotein (HDL)		12-week	Yes