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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360476
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : December 9, 2015
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Phillip D. Levy, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Hypertension Left Ventricular Hypertrophy Dietary Supplement: cholecalciferol (Vitamin D) Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adjunct Vitamin D Therapy as a Means to Reduce the Disparity in Subclinical Target Organ Cardiac Damage Among Vulnerable Hypertensive Patients
Study Start Date : August 2011
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D Dietary Supplement: cholecalciferol (Vitamin D)
50,000 UI, chewable wafer every 2 weeks for 52 weeks (27 total doses)

Placebo Comparator: placebo Dietary Supplement: Placebo
chewable wafer every 2 weeks for 52 weeks (27 total doses)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360476

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United States, Michigan
Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
National Institute on Minority Health and Health Disparities (NIMHD)
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Principal Investigator: Phillip D Levy, MD Wayne State University
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Responsible Party: Phillip D. Levy, Associate Director of Clinical Research, Wayne State University Identifier: NCT01360476    
Other Study ID Numbers: 1R01MD005849-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Keywords provided by Phillip D. Levy, Wayne State University:
left ventricular hypertrophy
Vitamin D
Additional relevant MeSH terms:
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Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Heart Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents