Vitamin D, Cardiovascular Disease, and African Americans
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Peripheral Vascular Disease, Gastrointestinal, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 50 - 70 |
| Updated: | 9/12/2018 |
| Start Date: | July 2012 |
| End Date: | December 2018 |
Vitamin D and Early Markers of Cardiovascular Disease in African Americans
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.
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.
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.
Inclusion Criteria:
- 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
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
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