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.
This study will be a double blinded, randomized controlled trial of vitamin D3 supplementation, 4,000 international units per day versus 600 international units per day, for one year to determine the effects on markers of subclinical cardiovascular disease in African Americans with type 2 diabetes and vitamin D deficiency. Outcome assessment will focus on changes in carotid intima-medial thickness (CIMT - ultrasound of the thickness of blood vessels in the neck), as well as markers of systemic inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Multivitamin containing cholecalciferol 4000 units orally daily
Multivitamin containing cholecalciferol 600 units orally daily
500 mg orally twice daily
Washington University
St Louis, Missouri, United States
Change from baseline in carotid intima-medial thickness
Time frame: 0, 6, and 12 months
Change from baseline in systemic inflammatory markers
Time frame: 0, 6, and 12 months
Serum calcium
Time frame: 0, 1, 3, 6, 9, and 12 months
Urinary Calcium
Time frame: 0, 1, 3, 6, 9, and 12 months
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