Vitamin D and Inflammatory Markers of Cardiovascular Disease in African Americans With Type 2 Diabetes
This trial is active, not recruiting.
|Conditions||vitamin d deficiency, diabetes|
|Treatments||ergocalciferol, placebo pill|
|Sponsor||John H. Stroger Hospital|
|Start date||April 2007|
|End date||June 2010|
|Trial size||117 participants|
|Trial identifier||NCT01153243, #07-061|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Levels of inflammatory markers
time frame: baseline and 12 weeks
Levels of Vitamin D, PTH and Calcium
time frame: Baseline and 12 weeks
Male or female participants of any age.
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
|Official title||Does Administration of Vitamin D in African Americans With Hypovitaminosis D and Type 2 DM Improve Inflammatory Markers of Cardiovascular Disease?|
|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.|
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