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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: plain yogurt drink
* Dietary Supplement: vitamin D fortified yogurt drink
* Dietary Supplement: vitamin D-calcium yogurt drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Plain yogurt drink<br>daily intake of two bottle (250 mL) plain yogurt drink | Dietary Supplement: plain yogurt drink<br>* daily intake of two bottle of plain yogurt drink<br>* Other names: PY;|
| Experimental: vitamin D-fortified yogurt drink<br>daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL | Dietary Supplement: vitamin D fortified yogurt drink<br>* daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D/250 mL<br>* Other names: DY;|
| Experimental: vitamin D-calcium yogurt drink<br>daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL | Dietary Supplement: vitamin D-calcium yogurt drink<br>* daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 ml package<br>* Other names: DCY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25-hydroxyvitamin D |  | 12-week | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D fortification, yogurt drink, type 2 diabetes, efficacy