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

Tracking Information

First Received Date ^ICMJE

October 27, 2010

Last Updated Date

December 10, 2011

Start Date ^ICMJE

October 2009

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01229891 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01229891

Other Study ID Numbers ^ICMJE

11024

Has Data Monitoring Committee

Yes

Responsible Party

Tirang R. Neyestani, National Nutrition and Food Technology Institute

Study Sponsor ^ICMJE

National Nutrition and Food Technology Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Tirang R. Neyestani, PhD

National Nutrition and Food Technology Research Institute

Information Provided By

National Nutrition and Food Technology Institute

Verification Date

December 2011

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

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