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Completed

NCT Number: NCT01229891

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

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).

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plain Yogurt Drink

Dietary Supplement

daily intake of two bottle of plain yogurt drink

Other names: PY

vitamin D fortified yogurt drink

Dietary Supplement

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

Other names: DY

vitamin D-calcium yogurt drink

Dietary Supplement

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

Other names: DCY

Primary outcomes

  1. Serum 25-hydroxyvitamin D

    Time frame: 12-week

Secondary outcomes

  1. Fasting Serum Glucose (FSG)

    Time frame: 12-week

  2. Insulin

    Time frame: 12-week

    fasting serum insulin concentration

  3. Hemoglobin A1c (HbA1c)

    Time frame: 12-week

  4. Serum Triglyceride (TG)

    Time frame: 12-week

  5. Serum Total Cholesterol (Tchol)

    Time frame: 12-week

  6. Serum Low Density Lipoprotein (LDL)

    Time frame: 12-week

  7. Serum High Density Lipoprotein (HDL)

    Time frame: 12-week

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 28, 2010
Registry last updated
Jan 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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