Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients (AdDReaCH)

Adjunct Vitamin D Therapy as a Means to Reduce the Disparity in Subclinical Target Organ 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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Left Ventricular Hypertrophy
• Intervention / Treatment: Dietary supplement: cholecalciferol (Vitamin D); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 354
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Detroit Receiving Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Dietary supplement: Placebo; chewable wafer every 2 weeks for 52 weeks (27 total doses)
Active Comparator: Vitamin D	Dietary supplement: cholecalciferol (Vitamin D); 50,000 UI, chewable wafer every 2 weeks for 52 weeks (27 total doses)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in left ventricular hypertrophy at 1 year	Cardiac MRI will be used to assess this change.	baseline, 16weeks, 52weeks

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Phillip D Levy, MD, Wayne State University

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 19, 2011
• First Submitted That Met QC Criteria: May 24, 2011
• First Posted (Estimate): May 25, 2011

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Vitamin D; hypertension; African-Americans; left ventricular hypertrophy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Cardiomegaly; Hypertension; Hypertrophy; Hypertrophy, Left Ventricular; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 1R01MD005849-01A1 (U.S. NIH Grant/Contract)