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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Wayne State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Phillip D. Levy, Wayne State University
ClinicalTrials.gov Identifier:
NCT01360476
First received: May 19, 2011
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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 Intervention
Hypertension
Left Ventricular Hypertrophy
Dietary Supplement: cholecalciferol (Vitamin D)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Change from Baseline in left ventricular hypertrophy at 1 year [ Time Frame: baseline, 16weeks, 52weeks ] [ Designated as safety issue: No ]
    Cardiac MRI will be used to assess this change.


Estimated Enrollment: 267
Study Start Date: August 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   30 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360476

Contacts
Contact: LynnMarie C Mango, MPH 313-966-7253 Lmmango@med.wayne.edu

Locations
United States, Michigan
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: LynnMarie Mango, MPH    313-966-7253    Lmmango@med.wayne.edu   
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Phillip D Levy, MD Wayne State University
  More Information

No publications provided

Responsible Party: Phillip D. Levy, Associate Director of Clinical Research, Wayne State University
ClinicalTrials.gov Identifier: NCT01360476     History of Changes
Other Study ID Numbers: 1 R01 MD005849-01A1
Study First Received: May 19, 2011
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wayne State University:
hypertension
left ventricular hypertrophy
Vitamin D
African-Americans

Additional relevant MeSH terms:
Hypertension
Hypertrophy
Hypertrophy, Left Ventricular
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Vitamin D
Ergocalciferols
Vitamins
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014