Vitamin D and Inflammatory Markers of Cardiovascular Disease in African Americans With Type 2 Diabetes
- Registration Number
- NCT01153243
- Lead Sponsor
- Cook County Health
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 117
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo pill Placebo pill The investigators will give intervention group 12 weeks of placebo pill (in pill every week) Ergocalciferol Ergocalciferol The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)
- Primary Outcome Measures
Name Time Method Levels of inflammatory markers baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method Levels of Vitamin D, PTH and Calcium Baseline and 12 weeks