Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension

NCT ID: NCT01472796

Last Updated: 2011-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-03-31

Brief Summary

In this research study, the goal is to find out if a currently FDA-approved medication called Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure and improve heart function in the African American population. High blood pressure occurs earlier in life in African Americans, is more severe, and is associated with greater organ damage in relation to uncontrolled hypertension. Having low levels of Vitamin D is also very common in the African American population. Research has shown that there may be a link between low Vitamin D levels and the ability of high blood pressure medications to be fully effective.

Detailed Description

The overarching hypothesis is that African Americans with hypertension have an overactive RAS (Renin Angiotensin System) in the body that is responsible for internally regulating blood pressure. Many blood pressure medications change regulation of the RAS system in order to keep blood pressure down. The purpose of this research study is to determine whether or not African American adults with hypertension have an overactive RAS system due to Vitamin D deficiency, resulting in the inability of the medication Tekturna to lower blood pressure. In this study, all participants will receive 300mg of Tekturna per day. Additionally half of the participants will randomly be selected to receive either 50,000 IU of Vitamin D (in its cholecalciferol form) orally once every other week or a vitamin D placebo once every other week. There will be 4 study visits over 18 weeks and follow up phone calls every two weeks for the duration of the study.

Specific Aims:

To demonstrate in African American Hypertensives consuming a calcium replete diet that Tekturna + Vitamin D will lower blood pressure more than Tekturna + placebo.

To demonstrate in African American hypertensives consuming a calcium replete diet that albuminuria will be lowered more with Tekturna + Vitamin D versus Tekturna + placebo.

To demonstrate in African American hypertensives consuming a calcium replete diet that Tekturna + Vitamin D will improve measures on non-invasively measured vascular function (peripheral vascular resistance, augmentation index, carotid-femoral pulse wave velocity and central aortic pressure) more than Tekturna + placebo.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tekturna (Aliskirin) with vit. D supplementation

Tekturna (Aliskiren) 300mg daily and vitamin D supplementation (50,000 IU)every other week.

Group Type: ACTIVE_COMPARATOR

Vitamin D (cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

Tekturna (Aliskirin) 300 mg per day supplemented with 50,000 IU Vitamin D every other week x 8 weeks

Tekturna (Aliskiren) with placebo

Tekturna (Aliskiren) 300mg per day supplemented with placebo (vitamin D)

Group Type: PLACEBO_COMPARATOR

Tekturna(Aliskiren) plus placebo

Intervention Type: DRUG

Aliskiren 300 mg per day supplemented with placebo

Interventions

Vitamin D (cholecalciferol)

Tekturna (Aliskirin) 300 mg per day supplemented with 50,000 IU Vitamin D every other week x 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Tekturna(Aliskiren) plus placebo

Aliskiren 300 mg per day supplemented with placebo

Intervention Type: DRUG

Other Intervention Names

Tekturna (Aliskirin); cholecalciferol; Tekturna (Aliskirin)

Eligibility Criteria

Inclusion Criteria

• Ages 30-74
• Systolic Blood Pressure 140-159 mm Hg and Diastolic Blood Pressure <100 OR Diastolic Blood Pressure 90-99mm Hg and Systolic Blood Pressure <160mm Hg
• Vitamin D deficiency: Serum 25-OH D >= 10 ng/ml (25 nmol/L) to < 20 ng/ml (50 nmol/L)
• Not using any antihypertensive medication(s) for the previous 3 months

Exclusion Criteria

• Cancer(other than skin) known HIV or other medical condition that might limit life expectancy.
• Pregnant or nursing
• Know adverse reactions to DRI's
• Hepatitis or liver enzyme elevations > 1.5x normal
• Estimated glomerular filtration rate (EGFR) <50 ml/min/1.7m2
• Diabetes Mellitus
• Serum calcium > 10.5 mg/dl or history of hypercalcemia
• History of primary hyperparathyroidism
• Sarcoidosis or other granulomatous disease
• Taking > 500 mg/d of supplemental elemental calcium
• Taking any drugs that decrease absorption of vitamin D, ex:xenical
• Taking the drug cyclosporine
• Taking any antihypertensive medications in the previous 3 months
• History of kidney stones
• Planning to move > 50 miles in the next 9 months

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

John M. Flack

Chairman, Dept. of Internal Medicine, Wayne State University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John M Flack, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Wayne State University, TRaCE Research Group

Locations

Wayne State University, 4201 St. Antoine

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carol A Muzyk, CCRP

Role: CONTACT

cmuzyk@med.wayne.edu

313-745-2378

Donna Ford

Role: CONTACT

888-235-5467

Facility Contacts

Carol A Muzyk, CCRP

Role: primary

cmuzyk@med.wayne.edu

313-745-2378

Donna Ford

Role: backup

888-235-5467

Other Identifiers

CSPP100AUS41T

Identifier Type: -

Identifier Source: org_study_id