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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
History of Changes
  Purpose

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).


Condition Intervention Phase
Type 2 Diabetes
 Dietary Supplement: plain yogurt drink
Dietary Supplement: vitamin D fortified yogurt drink
Dietary Supplement: vitamin D-calcium yogurt drink
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Nutrition and Food Technology Institute:

Primary Outcome Measures:
  • Serum 25-hydroxyvitamin D [ Time Frame: 12-week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 90
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Plain yogurt drink
daily intake of two bottle (250 mL) plain yogurt drink
 Dietary Supplement: plain yogurt drink
daily intake of two bottle of plain yogurt drink
Other Name: PY
Experimental: vitamin D-fortified yogurt drink
daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
 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
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
 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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229891

Sponsors and Collaborators
National Nutrition and Food Technology Institute
Investigators
Study Chair: Tirang R. Neyestani, PhD National Nutrition and Food Technology Research Institute
  More Information

No publications provided by National Nutrition and Food Technology Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tirang R. Neyestani, associate professor, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT01229891     History of Changes
Other Study ID Numbers: 11024
Study First Received: October 27, 2010
Results First Received: November 6, 2011
Last Updated: December 10, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by National Nutrition and Food Technology Institute:
vitamin D fortification
yogurt drink
type 2 diabetes
efficacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Calcium, Dietary
Vitamin D
 Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013