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

National Nutrition and Food Technology Institute

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: plain yogurt drink; Dietary Supplement: vitamin D-calcium yogurt drink; Dietary Supplement: vitamin D fortified yogurt drink

Study type: Interventional

Funder types: Other

Identifiers

NCT01229891

11024 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Plain yogurt drink

Placebo Comparator group

Description:

daily intake of two bottle (250 mL) plain yogurt drink

Treatment:

Dietary Supplement: plain yogurt drink

vitamin D-fortified yogurt drink

Experimental group

Description:

daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL

Treatment:

Dietary Supplement: vitamin D fortified yogurt drink

vitamin D-calcium yogurt drink

Experimental group

Description:

daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL

Treatment:

Dietary Supplement: vitamin D-calcium yogurt drink