Vitamin D, Cardiovascular Disease, and African Americans

Completed · Not applicable

Conditions studied: Vitamin D Deficiency, Type 2 Diabetes Mellitus, Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT01655810

Run by

Washington University School of Medicine

People needed

86

Starts

2012-08-13

Expected to finish

2018-02-09

Last updated by the study team

2020-06-05

Who can join

Age: 50 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• African Americans of both genders
• Age 50-70 years
• Type 2 diabetes (A1C < 9.0%), on stable therapy with oral medications, insulin, or a combination
• 25(OH)D level < 20 ng/ml
• BP < 140/90 mmHg; LDL < 140 mg/dl

You may not qualify if…

• 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

Where it is running

• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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