Vitamin D, Cardiovascular Disease, and African Americans

The Washington University

Status: Completed

Conditions: Vitamin D Deficiency; Type 2 Diabetes Mellitus; Cardiovascular Disease

Treatments: Dietary Supplement: Calcium carbonate; Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01655810

201102160

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 86 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups

Vitamin D 4000 IU

Active Comparator group

Description:

PO daily

Treatment:

Dietary Supplement: Calcium carbonate

Dietary Supplement: Vitamin D3

Dietary Supplement: Vitamin D3

Vitamin D 600 IU

Active Comparator group

Description:

PO daily

Treatment:

Dietary Supplement: Calcium carbonate

Dietary Supplement: Vitamin D3

Dietary Supplement: Vitamin D3