Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients

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.

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Key information

Conditions

Hypertension Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertrophy Hypertrophy, Left Ventricular Left Ventricular Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

30 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals with known HTN
African-American race (self reported)
Repeat SBP ≥ 160 mmHg within 1 hour of arrival
Age 30-74 years
Asymptomatic state (class I as defined by Goldman Specific Activity Scale)

Exclusion criteria

Dyspnea (exertional, rest or nocturnal) or chest pain as a primary or secondary chief complaint
Prior history of HF, coronary artery disease, myocardial infarction, cardiomyopathy (any), valvular heart disease (any) or renal failure with current, previous, or planned future dialysis
Acute illness or injury which necessitates hospital admission
Acute alcohol or cocaine intoxication or history of chronic alcohol (determined using the CAGE screening questions) or cocaine (self-reported) abuse
Acute or decompensated psychiatric disorder or any underlying psychiatric disorder or cognitive deficit which precludes effective on-going communication or ability to follow-up as required
Cancer (other than skin), HIV, or any other medical condition that might limit life expectancy
Hepatitis or liver enzyme (ALT, AST) elevations > 1.5x normal
Planned move > 50 miles in the next 9 months
History of kidney stones
GFR <30
Serum calcium > 10.5 mg/dl or known history of hypercalcemia
History of or known primary hyperparathyroidism
Sarcoidosis or other granulomatous disease
Pregnant or planning to become pregnant
Allergy or known hypersensitivity to gadolinium contrast
Severe claustrophobia

Treatment and study plan

cholecalciferol (Vitamin D)

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

Change from Baseline in left ventricular hypertrophy at 1 year

Time frame: baseline, 16weeks, 52weeks

Cardiac MRI will be used to assess this change.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Adjunct Vitamin D Therapy as a Means to Reduce the Disparity in Subclinical Target Organ Cardiac Damage Among Vulnerable Hypertensive Patients

Acronym: AdDReaCH

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: May 25, 2011
Registry last updated: Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed