NCT01472796

Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension

Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension (VDATH)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Wayne State University · Academic / Other
• Sex: All
• Age: 30 Years – 74 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D (cholecalciferol)	Tekturna (Aliskirin) 300 mg per day supplemented with 50,000 IU Vitamin D every other week x 8 weeks
DRUG	Tekturna(Aliskiren) plus placebo	Aliskiren 300 mg per day supplemented with placebo

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-07-01
• Completion: 2014-03-01
• First posted: 2011-11-16
• Last updated: 2011-11-16

Locations

1 site across 1 country: United States