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

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ClinicalTrials.gov Identifier: NCT01153243
Recruitment Status : Unknown
Verified March 2009 by John H. Stroger Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 30, 2010
Last Update Posted : April 7, 2011
Sponsor:
Collaborator:
Rush University
Information provided by:
John H. Stroger Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Diabetes Drug: Ergocalciferol Drug: Placebo pill Phase 4

Detailed Description:

Other questions in our study: In diabetic African American patients,

  1. Prevalence of vitamin D deficiency?
  2. 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Does Administration of Vitamin D in African Americans With Hypovitaminosis D and Type 2 DM Improve Inflammatory Markers of Cardiovascular Disease?
Study Start Date : April 2007
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ergocalciferol
The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)
 Drug: Ergocalciferol

Active Comparator: Ergocalciferol

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

Other Names:
  • Drisdol
  • Vitamin D
Placebo Comparator: Placebo pill
The investigators will give intervention group 12 weeks of placebo pill (in pill every week)
 Drug: Placebo pill
The investigators will give control group 12 weeks of 1 placebo pill every week.


Outcome Measures
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Primary Outcome Measures :
  1. Levels of inflammatory markers [ Time Frame: baseline and 12 weeks ]

Secondary Outcome Measures :
  1. Levels of Vitamin D, PTH and Calcium [ Time Frame: Baseline and 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153243


Sponsors and Collaborators
John H. Stroger Hospital
Rush University
Investigators
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Study Director: Leon Fogelfeld, MD John H. Stroger Hospital
More Information
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Responsible Party: Leon Fogelfeld MD, John H Stroger Hospital of Cook County
ClinicalTrials.gov Identifier: NCT01153243    
Other Study ID Numbers: #07-061
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: March 2009
Keywords provided by John H. Stroger Hospital:
inflammatory markers
Additional relevant MeSH terms:
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Cardiovascular Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
 Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents