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

This study is currently recruiting participants.
Verified November 2011 by Wayne State University
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
John M. Flack, Wayne State University
ClinicalTrials.gov Identifier:
NCT01472796
First received: November 11, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hypertension
 Dietary Supplement: Vitamin D (cholecalciferol)
Drug: Tekturna(Aliskiren) plus placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension (VDATH)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Change in Ambulatory Systolic Blood Pressure [ Time Frame: from baseline (Week 10) to Week 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in ambulatory diastolic blood pressure [ Time Frame: from baseline (Week 10) to Week 18 ] [ Designated as safety issue: No ]
  • Change in cuff systolic blood pressure [ Time Frame: from baseline (Week 10) to Week 18 ] [ Designated as safety issue: No ]
  • Change in cuff diastolic blood pressure [ Time Frame: from baseline (week 10) to Week 18 ] [ Designated as safety issue: No ]
  • Change in Urinary albumin:creatinine ratio [ Time Frame: from baseline (week 10) to Week 18 ] [ Designated as safety issue: No ]
  • Change in plasma isoprostanes [ Time Frame: from baseline (week 10) to Week 18 ] [ Designated as safety issue: No ]
  • Change in urinary nitric oxide metabolites [ Time Frame: from baseline (week 10) to Week 18 ] [ Designated as safety issue: No ]
  • Change in plasma renin activity [ Time Frame: from baseline (week 10) to Week 18 ] [ Designated as safety issue: No ]
  • Change in urinary angiotensinogen [ Time Frame: from baseline (week 10) to Week 18 ] [ Designated as safety issue: No ]
  • Change in non-invasively obtained measures of vascular function [ Time Frame: from baseline (week 10) to Week 18 ] [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: July 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Tekturna (Aliskirin)
  • cholecalciferol
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 Name: Tekturna (Aliskirin)

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.

  Eligibility

Ages Eligible for Study:   30 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472796

Contacts
Contact: Carol A Muzyk, CCRP 313-745-2378 cmuzyk@med.wayne.edu
Contact: Donna Ford 888-235-5467

Locations
United States, Michigan
Wayne State University, 4201 St. Antoine Recruiting
Detroit, Michigan, United States, 48201
Contact: Carol A Muzyk, CCRP     313-745-2378     cmuzyk@med.wayne.edu    
Contact: Donna Ford     888-235-5467        
Principal Investigator: John M Flack, M.D., M.P.H.            
Sponsors and Collaborators
Wayne State University
Novartis
Investigators
Principal Investigator: John M Flack, M.D., M.P.H. Wayne State University, TRaCE Research Group
  More Information

No publications provided

Responsible Party: John M. Flack, Chairman, Dept. of Internal Medicine, Wayne State University, Wayne State University
ClinicalTrials.gov Identifier: NCT01472796     History of Changes
Other Study ID Numbers: CSPP100AUS41T
Study First Received: November 11, 2011
Last Updated: November 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Wayne State University:
African American
Vitamin D deficient

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013