search
Back to results

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

Primary Purpose

Hypertension, Left Ventricular Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol (Vitamin D)
Placebo
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring hypertension, left ventricular hypertrophy, Vitamin D, African-Americans

Eligibility Criteria

30 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Detroit Receiving Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D

placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in left ventricular hypertrophy at 1 year
Cardiac MRI will be used to assess this change.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2011
Last Updated
December 8, 2015
Sponsor
Wayne State University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT01360476
Brief Title
Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients
Acronym
AdDReaCH
Official Title
Adjunct Vitamin D Therapy as a Means to Reduce the Disparity in Subclinical Target Organ Cardiac Damage Among Vulnerable Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Left Ventricular Hypertrophy
Keywords
hypertension, left ventricular hypertrophy, Vitamin D, African-Americans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol (Vitamin D)
Intervention Description
50,000 UI, chewable wafer every 2 weeks for 52 weeks (27 total doses)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
chewable wafer every 2 weeks for 52 weeks (27 total doses)
Primary Outcome Measure Information:
Title
Change from Baseline in left ventricular hypertrophy at 1 year
Description
Cardiac MRI will be used to assess this change.
Time Frame
baseline, 16weeks, 52weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip D Levy, MD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients

We'll reach out to this number within 24 hrs