NCT01360476

Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients

Adjunct Vitamin D Therapy as a Means to Reduce the Disparity in Subclinical Target Organ Cardiac Damage Among Vulnerable Hypertensive Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Wayne State University · Academic / Other
• Sex: All
• Age: 30 Years – 74 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cholecalciferol (Vitamin D)	50,000 UI, chewable wafer every 2 weeks for 52 weeks (27 total doses)
DIETARY_SUPPLEMENT	Placebo	chewable wafer every 2 weeks for 52 weeks (27 total doses)

Timeline

• Start date: 2011-08-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2011-05-25
• Last updated: 2015-12-09

Locations

1 site across 1 country: United States