Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients

Summary

This project seeks to reduce the disparity in hypertensive heart disease which exists for African-Americans who have poorly controlled hypertension (HTN), also known as blood pressure (BP). The investigators are targeting a highly vulnerable, often neglected subject population which stands to benefit tremendously from better BP control and a corresponding decrease in heart damage. HTN occurs early in life and more often in African-Americans, reducing both quality and quantity of life. Inner-city African-Americans with HTN utilize the emergency department (ED) for chronic BP management. Like cardiovascular disease, vitamin D deficiency disproportionately affects African-Americans. Vitamin D is thought to play an important role in cardiovascular health. Vitamin D replacement in those who are deficient has been thought to reduce the cardiovascular disease, especially if initiated early before irreversible damage has occurred, but this has yet to be tested in a prospective clinical trial. Accordingly, this proposal was designed to investigate the relationship between vitamin D and cardiac damage (as identified on cardiac magnetic resonance imaging) in a cohort of African-American, vitamin D deficient hypertensive patients without prior history of heart disease.

The primary objective of this proposal is to evaluate the efficacy of vitamin D therapy in vitamin D deficient African-Americans with HTN. Vitamin D is an inexpensive treatment, which, if shown to be effective could improve the existing approach to a widely accessible, cost-effective option.

Conditions

• Hypertension
• Left Ventricular Hypertrophy

Interventions

DIETARY_SUPPLEMENT

cholecalciferol (Vitamin D)

50,000 UI, chewable wafer every 2 weeks for 52 weeks (27 total doses)

DIETARY_SUPPLEMENT

Placebo

chewable wafer every 2 weeks for 52 weeks (27 total doses)

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• Wayne State University

  lead OTHER

Principal Investigators

• Phillip D Levy, MD · Wayne State University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2015-11-30

Completion

2015-11-30

Countries

• United States

Study Locations