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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: plain yogurt drink; Dietary Supplement: vitamin D fortified yogurt drink; Dietary Supplement: vitamin D-calcium yogurt drink

• Registration Number: NCT01229891
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-03
• Study Completion: 2010-09
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Results First Submitted: 2011-11-06
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-10
• Last Update Submitted: 2011-12-10
• Results First Posted: 2012-01-16
• Last Update Posted: 2012-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plain yogurt drink	plain yogurt drink	daily intake of two bottle (250 mL) plain yogurt drink
vitamin D-fortified yogurt drink	vitamin D fortified yogurt drink	daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
vitamin D-calcium yogurt drink	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

Primary Outcome Measures

Name	Time	Method
Serum 25-hydroxyvitamin D	12-week

Secondary Outcome Measures

Name	Time	Method
Serum Low Density Lipoprotein (LDL)	12-week
Serum High Density Lipoprotein (HDL)	12-week
Fasting Serum Glucose (FSG)	12-week
Insulin	12-week	fasting serum insulin concentration
Hemoglobin A1c (HbA1c)	12-week
Serum Triglyceride (TG)	12-week
Serum Total Cholesterol (Tchol)	12-week