Vitamin D and Cardiovascular Disease in African Americans
Active study, but not enrolling
Title of study
Vitamin D and Early Markers of Cardiovascular Disease in African Americans
Eligibility
Ages Eligible for Study: 45 to 80 years
Genders Eligible for Study: Both
Ethnic/Racial Eligible for Study: Black or African American
Accepts Healthy Volunteers: No
Inclusion criteria
• Type 2 diabetes (A1C < 9.0%), on stable therapy with oral medications, insulin, or a combination
• 25(OH)D level < 25 ng/ml
• BP < 140/90 mmHg; LDL < 140 mg/dl
Exclusion criteria
• Pregnancy
• Cardiovascular disease
• Stage 3 or worse chronic kidney disease
• High urine or serum calcium or history of recurrent kidney stones
• Unstable medical conditions or major systemic diseases such as malignancy
Purpose
African-Americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin D deficiency. Multiple observational studies have demonstrated an increased risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation between cardiovascular disease and vitamin D levels; however, there is a lack of interventional trials exploring this connection. The objective of this proposal is to address the hypothesis that treatment of vitamin D deficiency in African Americans with type 2 diabetes will improve subclinical markers of cardiovascular disease.
Primary outcome measures
Change from baseline in carotid intima-medial thickness
Investigators
Principal Investigator
Carlos Bernal-Mizrachi, MD
Co-Investigator
Amy E. Riek, MD
Contact information
Phone
314-362-0934