Vitamin D Therapy to Reduce Cardiac Damage Among Vulnerable Hypertensive Patients

Hypertension Clinical Trial

— AdDReaCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360476
• Other study ID #: 1R01MD005849-01A1
• Status: Completed
• Phase: N/A
• First received: May 19, 2011
• Last updated: December 8, 2015
• Start date: August 2011
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

Intervention

Dietary Supplement:
• cholecalciferol (Vitamin D)
50,000 UI, chewable wafer every 2 weeks for 52 weeks (27 total doses)
• Placebo
chewable wafer every 2 weeks for 52 weeks (27 total doses)

Locations

Country	Name	City	State
United States	Detroit Receiving Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in left ventricular hypertrophy at 1 year	Cardiac MRI will be used to assess this change.	baseline, 16weeks, 52weeks	No