Vitamin D, Cardiovascular Disease, and African Americans
NCT01655810 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2020-06-05
Summary
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.
Conditions
- Vitamin D Deficiency
- Type 2 Diabetes Mellitus
- Cardiovascular Disease
Interventions
- DIETARY_SUPPLEMENT
-
Vitamin D3
Multivitamin containing cholecalciferol 4000 units orally daily
- DIETARY_SUPPLEMENT
-
Vitamin D3
Multivitamin containing cholecalciferol 600 units orally daily
- DIETARY_SUPPLEMENT
-
Calcium carbonate
500 mg orally twice daily
Sponsors & Collaborators
- collaborator OTHER
-
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Carlos Bernal-Mizrachi, MD · Washington University School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-13
- Primary Completion
- 2018-02-09
- Completion
- 2018-02-09
Countries
- United States
Study Locations
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