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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by John H. Stroger Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Rush University
Information provided by:
John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT01153243
First received: March 23, 2010
Last updated: April 6, 2011
Last verified: March 2009
  Purpose

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 Intervention Phase
Vitamin D Deficiency
Diabetes
Drug: Ergocalciferol
Drug: Placebo pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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?

Resource links provided by NLM:


Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • Levels of inflammatory markers [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Levels of Vitamin D, PTH and Calcium [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: April 2007
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153243

Sponsors and Collaborators
John H. Stroger Hospital
Rush University
Investigators
Study Director: Leon Fogelfeld, MD John H. Stroger Hospital
  More Information

No publications provided

Responsible Party: Leon Fogelfeld MD, John H Stroger Hospital of Cook County
ClinicalTrials.gov Identifier: NCT01153243     History of Changes
Other Study ID Numbers: #07-061
Study First Received: March 23, 2010
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by John H. Stroger Hospital:
inflammatory markers

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Malnutrition
Metabolic Diseases
Nutrition Disorders
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014