Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients (AdDReaCH)
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|ClinicalTrials.gov Identifier: NCT01360476|
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : December 9, 2015
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||354 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|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)
- Change from Baseline in left ventricular hypertrophy at 1 year [ Time Frame: baseline, 16weeks, 52weeks ]Cardiac MRI will be used to assess this change.
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 ClinicalTrials.gov identifier (NCT number): NCT01360476
|United States, Michigan|
|Detroit Receiving Hospital|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Phillip D Levy, MD||Wayne State University|