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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tirang R. Neyestani, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:
NCT01229891
First received: October 27, 2010
Last updated: December 10, 2011
Last verified: December 2011

October 27, 2010
December 10, 2011
October 2009
March 2010   (final data collection date for primary outcome measure)
Serum 25-hydroxyvitamin D [ Time Frame: 12-week ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT01229891 on ClinicalTrials.gov Archive Site
  • Fasting Serum Glucose (FSG) [ Time Frame: 12-week ] [ Designated as safety issue: Yes ]
  • Insulin [ Time Frame: 12-week ] [ Designated as safety issue: Yes ]
    fasting serum insulin concentration
  • Hemoglobin A1c (HbA1c) [ Time Frame: 12-week ] [ Designated as safety issue: Yes ]
  • Serum Triglyceride (TG) [ Time Frame: 12-week ] [ Designated as safety issue: Yes ]
  • Serum Total Cholesterol (Tchol) [ Time Frame: 12-week ] [ Designated as safety issue: Yes ]
  • Serum Low Density Lipoprotein (LDL) [ Time Frame: 12-week ] [ Designated as safety issue: Yes ]
  • Serum High Density Lipoprotein (HDL) [ Time Frame: 12-week ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Comparison of Efficacy of Vitamin D and Vitamin D-calcium Fortified Yogurt Drink in Diabetic Patients
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

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Type 2 Diabetes
  • Dietary Supplement: plain yogurt drink
    daily intake of two bottle of plain yogurt drink
    Other Name: PY
  • Dietary Supplement: vitamin D fortified yogurt drink
    daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D/250 mL
    Other Name: DY
  • Dietary Supplement: 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
    Other Name: DCY
  • Placebo Comparator: Plain yogurt drink
    daily intake of two bottle (250 mL) plain yogurt drink
    Intervention: Dietary Supplement: plain yogurt drink
  • Experimental: vitamin D-fortified yogurt drink
    daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
    Intervention: Dietary Supplement: vitamin D fortified yogurt drink
  • Experimental: 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
    Intervention: Dietary Supplement: vitamin D-calcium yogurt drink

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
September 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
30 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01229891
11024
Yes
Tirang R. Neyestani, National Nutrition and Food Technology Institute
National Nutrition and Food Technology Institute
Not Provided
Study Chair: Tirang R. Neyestani, PhD National Nutrition and Food Technology Research Institute
National Nutrition and Food Technology Institute
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP