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

Sponsor
National Nutrition and Food Technology Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01229891
Collaborator
(none)
90
Enrollment
3
Arms
11
Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: plain yogurt drink
  • Dietary Supplement: vitamin D fortified yogurt drink
  • Dietary Supplement: vitamin D-calcium yogurt drink
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
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
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum 25-hydroxyvitamin D [12-week]

    Secondary Outcome Measures

    1. Fasting Serum Glucose (FSG) [12-week]

    2. Insulin [12-week]

      fasting serum insulin concentration

    3. Hemoglobin A1c (HbA1c) [12-week]

    4. Serum Triglyceride (TG) [12-week]

    5. Serum Total Cholesterol (Tchol) [12-week]

    6. Serum Low Density Lipoprotein (LDL) [12-week]

    7. Serum High Density Lipoprotein (HDL) [12-week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Nutrition and Food Technology Institute

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tirang R. Neyestani, associate professor, National Nutrition and Food Technology Institute
    ClinicalTrials.gov Identifier:
    NCT01229891
    Other Study ID Numbers:
    • 11024
    First Posted:
    Oct 28, 2010
    Last Update Posted:
    Jan 16, 2012
    Last Verified:
    Dec 1, 2011
    Keywords provided by Tirang R. Neyestani, associate professor, National Nutrition and Food Technology Institute
    vitamin D fortification
    yogurt drink
    type 2 diabetes
    efficacy
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Vitamin D
    Ergocalciferols
    Cholecalciferol
    Vitamins

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink
    Arm/Group Description daily intake of two bottle (250 mL) plain yogurt drink daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
    Period Title: Overall Study
    STARTED 30 30 30
    COMPLETED 30 30 30
    NOT COMPLETED 0 0 0

    Baseline Characteristics

    Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink Total
    Arm/Group Description daily intake of two bottle (250 mL) plain yogurt drink daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL Total of all reporting groups
    Overall Participants 30 30 30 90
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    50.8
    (6.6)
    51.4
    (5.4)
    49.9
    (6.2)
    50.7
    (6.1)
    Sex: Female, Male (Count of Participants)
    Female
    18
    60%
    16
    53.3%
    9
    30%
    43
    47.8%
    Male
    12
    40%
    14
    46.7%
    21
    70%
    47
    52.2%
    25-hydroxyvitamin D (nmol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [nmol/L]
    50
    (26)
    47.5
    (27)
    51.3
    (43)
    48.8
    (38.4)
    Fasting serum glucose (FSG) (mg/dL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dL]
    187
    (57.1)
    184.1
    (63.8)
    184
    (57.3)
    185
    (58.8)
    Insulin (mU/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mU/L]
    7.7
    (3.2)
    7.7
    (4.6)
    7.6
    (4.6)
    7.6
    (4.1)
    HbA1c (percent) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [percent]
    7.5
    (1.5)
    7.4
    (1.8)
    7.8
    (1.9)
    7.6
    (1.7)
    TG (mg/dL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dL]
    160.5
    (100.7)
    155.4
    (65.9)
    176.6
    (91.0)
    164.2
    (86.6)
    Tchol (mg/dL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dL]
    187.5
    (43.3)
    177.5
    (41.9)
    187.7
    (46.6)
    182.4
    (43.8)
    LDL (mg/dL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dL]
    88.6
    (25.9)
    87.2
    (25.1)
    90.2
    (27.9)
    88.7
    (26.0)
    HDL (mg/dL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dL]
    50.8
    (8.2)
    46
    (9.6)
    47.2
    (9.4)
    48
    (9.2)

    Outcome Measures

    1. Primary Outcome
    Title Serum 25-hydroxyvitamin D
    Description
    Time Frame 12-week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
    Arm/Group Description 2 bottle plain yogurt drink per day 2 bottle vitamin D-fortified yogurt drink per day 2 bottle vitamin D-calcium-fortified yogurt drink per day
    Measure Participants 30 30 30
    Mean (Standard Deviation) [nmol/L]
    45.6
    (45.4)
    76.2
    (28.4)
    78.4
    (40.8)
    2. Secondary Outcome
    Title Fasting Serum Glucose (FSG)
    Description
    Time Frame 12-week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
    Arm/Group Description 2 bottle plain yogurt drink per day 2 bottle vitamin D-fortified yogurt drink per day 2 bottle vitamin D-calcium-fortified yogurt drink per day
    Measure Participants 30 30 30
    Mean (Standard Deviation) [mg/dL]
    203.3
    (64.4)
    171.2
    (59.2)
    174.3
    (50)
    3. Secondary Outcome
    Title Insulin
    Description fasting serum insulin concentration
    Time Frame 12-week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
    Arm/Group Description 2 bottle plain yogurt drink per day 2 bottle vitamin D-fortified yogurt drink per day 2 bottle vitamin D-calcium-fortified yogurt drink per day
    Measure Participants 30 30 30
    Mean (Standard Deviation) [mU/L]
    10.8
    (5.5)
    6.5
    (3.3)
    6.4
    (3.1)
    4. Secondary Outcome
    Title Hemoglobin A1c (HbA1c)
    Description
    Time Frame 12-week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
    Arm/Group Description 2 bottle plain yogurt drink per day 2 bottle vitamin D-fortified yogurt drink per day 2 bottle vitamin D-calcium-fortified yogurt drink per day
    Measure Participants 30 30 30
    Mean (Standard Deviation) [percent]
    8.7
    (1.4)
    7
    (2.3)
    7.8
    (1.9)
    5. Secondary Outcome
    Title Serum Triglyceride (TG)
    Description
    Time Frame 12-week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
    Arm/Group Description 2 bottle plain yogurt drink per day 2 bottle vitamin D-fortified yogurt drink per day 2 bottle vitamin D-calcium-fortified yogurt drink per day
    Measure Participants 30 30 30
    Mean (Standard Deviation) [mg/dL]
    181.3
    (91.8)
    155.2
    (55.1)
    161.1
    (64.3)
    6. Secondary Outcome
    Title Serum Total Cholesterol (Tchol)
    Description
    Time Frame 12-week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
    Arm/Group Description 2 bottle plain yogurt drink per day 2 bottle vitamin D-fortified yogurt drink per day 2 bottle vitamin D-calcium-fortified yogurt drink per day
    Measure Participants 30 30 30
    Mean (Standard Deviation) [mg/dL]
    197.3
    (48.1)
    182.8
    (43.0)
    178.5
    (42.4)
    7. Secondary Outcome
    Title Serum Low Density Lipoprotein (LDL)
    Description
    Time Frame 12-week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
    Arm/Group Description 2 bottle plain yogurt drink per day 2 bottle vitamin D-fortified yogurt drink per day 2 bottle vitamin D-calcium-fortified yogurt drink per day
    Measure Participants 30 30 30
    Mean (Standard Deviation) [mg/dL]
    93.5
    (24.9)
    91.1
    (19.8)
    96.3
    (27.8)
    8. Secondary Outcome
    Title Serum High Density Lipoprotein (HDL)
    Description
    Time Frame 12-week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Fortified Yogurt Drink
    Arm/Group Description 2 bottle plain yogurt drink per day 2 bottle vitamin D-fortified yogurt drink per day 2 bottle vitamin D-calcium-fortified yogurt drink per day
    Measure Participants 30 30 30
    Mean (Standard Deviation) [mg/dL]
    51.8
    (9.6)
    46.1
    (10)
    48
    (6.8)

    Adverse Events

    Time Frame during the intervention (12-week)
    Adverse Event Reporting Description
    Arm/Group Title Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink
    Arm/Group Description daily intake of two bottle (250 mL) plain yogurt drink daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
    All Cause Mortality
    Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/30 (0%) 0/30 (0%) 0/30 (0%)
    Other (Not Including Serious) Adverse Events
    Plain Yogurt Drink Vitamin D-fortified Yogurt Drink Vitamin D-calcium Yogurt Drink
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/30 (0%) 0/30 (0%) 0/30 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title T Neyestani
    Organization National nutrition and food technology institute
    Phone 0982122376471
    Email neytr@yahoo.com
    Responsible Party:
    Tirang R. Neyestani, associate professor, National Nutrition and Food Technology Institute
    ClinicalTrials.gov Identifier:
    NCT01229891
    Other Study ID Numbers:
    • 11024
    First Posted:
    Oct 28, 2010
    Last Update Posted:
    Jan 16, 2012
    Last Verified:
    Dec 1, 2011