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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: Vitamin D (cholecalciferol); Drug: Tekturna(Aliskiren) plus placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Wayne State University, 4201 St. Antoine
      • Contact: Carol A Muzyk, CCRP; Phone Number: 313-745-2378; Email: cmuzyk@med.wayne.edu
      • Contact: Donna Ford; Phone Number: 888-235-5467
      • Principal Investigator: John M Flack, M.D., M.P.H.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tekturna (Aliskirin) with vit. D supplementation; Tekturna (Aliskiren) 300mg daily and vitamin D supplementation (50,000 IU)every other week.	Dietary supplement: Vitamin D (cholecalciferol); Tekturna (Aliskirin) 300 mg per day supplemented with 50,000 IU Vitamin D every other week x 8 weeks; Other Names: cholecalciferol; Tekturna (Aliskirin)
Placebo Comparator: Tekturna (Aliskiren) with placebo; Tekturna (Aliskiren) 300mg per day supplemented with placebo (vitamin D)	Drug: Tekturna(Aliskiren) plus placebo; Aliskiren 300 mg per day supplemented with placebo; Other Names: Tekturna (Aliskirin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Ambulatory Systolic Blood Pressure	from baseline (Week 10) to Week 18

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in ambulatory diastolic blood pressure	from baseline (Week 10) to Week 18
Change in cuff systolic blood pressure	from baseline (Week 10) to Week 18
Change in cuff diastolic blood pressure	from baseline (week 10) to Week 18
Change in Urinary albumin:creatinine ratio	from baseline (week 10) to Week 18
Change in plasma isoprostanes	from baseline (week 10) to Week 18
Change in urinary nitric oxide metabolites	from baseline (week 10) to Week 18
Change in plasma renin activity	from baseline (week 10) to Week 18
Change in urinary angiotensinogen	from baseline (week 10) to Week 18
Change in non-invasively obtained measures of vascular function	from baseline (week 10) to Week 18

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: Novartis
• Investigators: Principal Investigator: John M Flack, M.D., M.P.H., Wayne State University, TRaCE Research Group

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: November 11, 2011
• First Submitted That Met QC Criteria: November 11, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): November 16, 2011
• Last Update Submitted That Met QC Criteria: November 11, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: African American; Vitamin D deficient
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: CSPP100AUS41T