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The Role of Vitamin D3 and Calcium Supplementation in Attenuating T2DM Severity

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
vitamin D3 and calcium
Placebo
Sponsored by
York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring serum calcidiol, T2DM, vitamin D3 supplementation, post-menopausal women, ethnic diverse, calcium supplementation

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Non-white, post menopausal female
  • Have access to Community Health Center

Exclusion Criteria:

  • neurodegenerative disease
  • kideny disease
  • gluten allergy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    CaD Group

    Placebo Group

    Arm Description

    This arm received total of 1800 IU of vitamin D3 and 720 mg of calcium

    This arm received rice powder pills

    Outcomes

    Primary Outcome Measures

    Serum calcidiol

    Secondary Outcome Measures

    Fasting insulin
    Parathyroid Hormone
    Fasting blood glucose
    Glycated Hemoglobin

    Full Information

    First Posted
    June 3, 2015
    Last Updated
    June 4, 2015
    Sponsor
    York University
    Collaborators
    Women's Health in Women's Hands Community Health Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02464462
    Brief Title
    The Role of Vitamin D3 and Calcium Supplementation in Attenuating T2DM Severity
    Official Title
    The Role of Vitamin D and Calcium Supplementation in the Pathogenesis of Type 2 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    August 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    York University
    Collaborators
    Women's Health in Women's Hands Community Health Center

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the effect of vitamin D3 and calcium supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic patiens.
    Detailed Description
    Subjects of this study received a total of 1800 IU vitamin D3 and 720 mg of calcium per day for 3 years. The study was conducted in Toronto, Ontario, Canada.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    serum calcidiol, T2DM, vitamin D3 supplementation, post-menopausal women, ethnic diverse, calcium supplementation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CaD Group
    Arm Type
    Experimental
    Arm Description
    This arm received total of 1800 IU of vitamin D3 and 720 mg of calcium
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    This arm received rice powder pills
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    vitamin D3 and calcium
    Intervention Description
    1800 IU vitamin D3 plus 720 mg Calcium
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Rice powder pills
    Primary Outcome Measure Information:
    Title
    Serum calcidiol
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Fasting insulin
    Time Frame
    3 years
    Title
    Parathyroid Hormone
    Time Frame
    3 years
    Title
    Fasting blood glucose
    Time Frame
    3 years
    Title
    Glycated Hemoglobin
    Time Frame
    3 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Type 2 diabetes mellitus Non-white, post menopausal female Have access to Community Health Center Exclusion Criteria: neurodegenerative disease kideny disease gluten allergy

    12. IPD Sharing Statement

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