Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients

NCT ID: NCT01360476

Last Updated: 2015-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2015-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D

Group Type: ACTIVE_COMPARATOR

cholecalciferol (Vitamin D)

Intervention Type: DIETARY_SUPPLEMENT

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

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

cholecalciferol (Vitamin D)

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Phillip D. Levy

Associate Director of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Phillip D Levy, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Detroit Receiving Hospital

Detroit, Michigan, United States

Countries

United States

Other Identifiers

1R01MD005849-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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