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

April 6, 2011 updated by: John H. Stroger Hospital

Does Administration of Vitamin D in African Americans With Hypovitaminosis D and Type 2 DM Improve Inflammatory Markers of Cardiovascular Disease?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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:
  • Vitamin D
  • Drisdol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Levels of inflammatory markers
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Levels of Vitamin D, PTH and Calcium
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John H. Stroger Hospital

Collaborators

Rush University

Investigators

  • Study Director: Leon Fogelfeld, MD, John H. Stroger Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

June 29, 2010

First Posted (Estimate)

June 30, 2010

Study Record Updates

Last Update Posted (Estimate)

April 7, 2011

Last Update Submitted That Met QC Criteria

April 6, 2011

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #07-061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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