Vitamin D, Cardiovascular Disease, and African Americans

Vitamin D and Early Markers of Cardiovascular Disease in African Americans

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01655810

Enrollment

Registered

2012-08-02

Start date

2012-08-13

Completion date

2018-02-09

Last updated

2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Type 2 Diabetes Mellitus, Vitamin D Deficiency

Brief 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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTVitamin D3

Multivitamin containing cholecalciferol 4000 units orally daily

DIETARY_SUPPLEMENTCalcium carbonate

500 mg orally twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in carotid intima-medial thickness	0, 6, and 12 months

Secondary

Measure	Time frame
Change from baseline in systemic inflammatory markers	0, 6, and 12 months
Serum calcium	0, 1, 3, 6, 9, and 12 months
Urinary Calcium	0, 1, 3, 6, 9, and 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026