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

December 10, 2011 updated by: Tirang R. Neyestani, National Nutrition and Food Technology Institute

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • DCY

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum 25-hydroxyvitamin D
Time Frame: 12-week
12-week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Investigators

  • Study Chair: Tirang R. Neyestani, PhD, National Nutrition and Food Technology Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 27, 2010

First Submitted That Met QC Criteria

October 27, 2010

First Posted (Estimate)

October 28, 2010

Study Record Updates

Last Update Posted (Estimate)

January 16, 2012

Last Update Submitted That Met QC Criteria

December 10, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11024 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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