- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01153243
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,
- 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.
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)
|
Active Comparator: Ergocalciferol The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)
Other Names:
|
Placebo Comparator: Placebo pill
The investigators will give intervention group 12 weeks of placebo pill (in pill every week)
|
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
Collaborators
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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