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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vitamin D (cholecalciferol)
Tekturna(Aliskiren) plus placebo
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring African American, Vitamin D deficient

Eligibility Criteria

30 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wayne State University, 4201 St. AntoineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tekturna (Aliskirin) with vit. D supplementation

Tekturna (Aliskiren) with placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Ambulatory Systolic Blood Pressure

Secondary Outcome Measures

Change in ambulatory diastolic blood pressure
Change in cuff systolic blood pressure
Change in cuff diastolic blood pressure
Change in Urinary albumin:creatinine ratio
Change in plasma isoprostanes
Change in urinary nitric oxide metabolites
Change in plasma renin activity
Change in urinary angiotensinogen
Change in non-invasively obtained measures of vascular function

Full Information

First Posted
November 11, 2011
Last Updated
November 11, 2011
Sponsor
Wayne State University
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01472796
Brief Title
Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension
Acronym
VDATH
Official Title
Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension (VDATH)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
African American, Vitamin D deficient

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tekturna (Aliskirin) with vit. D supplementation
Arm Type
Active Comparator
Arm Description
Tekturna (Aliskiren) 300mg daily and vitamin D supplementation (50,000 IU)every other week.
Arm Title
Tekturna (Aliskiren) with placebo
Arm Type
Placebo Comparator
Arm Description
Tekturna (Aliskiren) 300mg per day supplemented with placebo (vitamin D)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D (cholecalciferol)
Other Intervention Name(s)
Tekturna (Aliskirin), cholecalciferol
Intervention Description
Tekturna (Aliskirin) 300 mg per day supplemented with 50,000 IU Vitamin D every other week x 8 weeks
Intervention Type
Drug
Intervention Name(s)
Tekturna(Aliskiren) plus placebo
Other Intervention Name(s)
Tekturna (Aliskirin)
Intervention Description
Aliskiren 300 mg per day supplemented with placebo
Primary Outcome Measure Information:
Title
Change in Ambulatory Systolic Blood Pressure
Time Frame
from baseline (Week 10) to Week 18
Secondary Outcome Measure Information:
Title
Change in ambulatory diastolic blood pressure
Time Frame
from baseline (Week 10) to Week 18
Title
Change in cuff systolic blood pressure
Time Frame
from baseline (Week 10) to Week 18
Title
Change in cuff diastolic blood pressure
Time Frame
from baseline (week 10) to Week 18
Title
Change in Urinary albumin:creatinine ratio
Time Frame
from baseline (week 10) to Week 18
Title
Change in plasma isoprostanes
Time Frame
from baseline (week 10) to Week 18
Title
Change in urinary nitric oxide metabolites
Time Frame
from baseline (week 10) to Week 18
Title
Change in plasma renin activity
Time Frame
from baseline (week 10) to Week 18
Title
Change in urinary angiotensinogen
Time Frame
from baseline (week 10) to Week 18
Title
Change in non-invasively obtained measures of vascular function
Time Frame
from baseline (week 10) to Week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol A Muzyk, CCRP
Phone
313-745-2378
Email
cmuzyk@med.wayne.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Ford
Phone
888-235-5467
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Flack, M.D., M.P.H.
Organizational Affiliation
Wayne State University, TRaCE Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University, 4201 St. Antoine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol A Muzyk, CCRP
Phone
313-745-2378
Email
cmuzyk@med.wayne.edu
First Name & Middle Initial & Last Name & Degree
Donna Ford
Phone
888-235-5467
First Name & Middle Initial & Last Name & Degree
John M Flack, M.D., M.P.H.

12. IPD Sharing Statement

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Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension

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