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Vitamin D and Inflammatory Markers of Cardiovascular Disease in African Americans With Type 2 Diabetes

Primary Purpose

Vitamin D Deficiency, Diabetes

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ergocalciferol
Placebo pill
Sponsored by
Cook County Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring inflammatory markers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • African Americans
  • DM type 2

Exclusion Criteria:

  • symptomatic vitamin D deficiency
  • hypocalcemia
  • hypercalcemia
  • malabsorption
  • liver disease
  • patients with creatinine > 1.5. (CKD >/= 3)
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Ergocalciferol

    Placebo pill

    Arm Description

    The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)

    The investigators will give intervention group 12 weeks of placebo pill (in pill every week)

    Outcomes

    Primary Outcome Measures

    Levels of inflammatory markers

    Secondary Outcome Measures

    Levels of Vitamin D, PTH and Calcium

    Full Information

    First Posted
    March 23, 2010
    Last Updated
    April 6, 2011
    Sponsor
    Cook County Health
    Collaborators
    Rush University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01153243
    Brief Title
    Vitamin D and Inflammatory Markers of Cardiovascular Disease in African Americans With Type 2 Diabetes
    Official Title
    Does Administration of Vitamin D in African Americans With Hypovitaminosis D and Type 2 DM Improve Inflammatory Markers of Cardiovascular Disease?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2007 (undefined)
    Primary Completion Date
    June 2010 (Anticipated)
    Study Completion Date
    June 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Cook County Health
    Collaborators
    Rush University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Recent clinical trials in non diabetics showed that vitamin D supplementation markedly reduced serum levels of C-reactive protein (CRP), interleukin-6, and tissue matrix metallo-proteinases. Our study objective is to evaluate if administration of vitamin D in African Americans with hypovitaminosis D and DM Type 2 decreases serum levels of inflammatory/thrombotic markers such as CRP: Highly Sensitive C Reactive Protein.
    Detailed Description
    Other questions in our study: In diabetic African American patients, Prevalence of vitamin D deficiency? Correlation/relationship between vitamin D levels, Calcium level, parathyroid hormone (PTH) and Inflammatory markers Setting: All visits will take place at the Fantus Diabetes Clinic.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin D Deficiency, Diabetes
    Keywords
    inflammatory markers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    117 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ergocalciferol
    Arm Type
    Active Comparator
    Arm Description
    The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)
    Arm Title
    Placebo pill
    Arm Type
    Placebo Comparator
    Arm Description
    The investigators will give intervention group 12 weeks of placebo pill (in pill every week)
    Intervention Type
    Drug
    Intervention Name(s)
    Ergocalciferol
    Other Intervention Name(s)
    Drisdol, Vitamin D
    Intervention Description
    Active Comparator: Ergocalciferol The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo pill
    Intervention Description
    The investigators will give control group 12 weeks of 1 placebo pill every week.
    Primary Outcome Measure Information:
    Title
    Levels of inflammatory markers
    Time Frame
    baseline and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Levels of Vitamin D, PTH and Calcium
    Time Frame
    Baseline and 12 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: African Americans DM type 2 Exclusion Criteria: symptomatic vitamin D deficiency hypocalcemia hypercalcemia malabsorption liver disease patients with creatinine > 1.5. (CKD >/= 3) pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leon Fogelfeld, MD
    Organizational Affiliation
    Cook County Health
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Vitamin D and Inflammatory Markers of Cardiovascular Disease in African Americans With Type 2 Diabetes

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