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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by John M. Flack, Wayne State University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01472796
First Posted: November 16, 2011
Last Update Posted: November 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
John M. Flack, Wayne State University
November 11, 2011
November 16, 2011
November 16, 2011
July 2011
July 2013   (Final data collection date for primary outcome measure)
Change in Ambulatory Systolic Blood Pressure [ Time Frame: from baseline (Week 10) to Week 18 ]
Same as current
No Changes Posted
  • Change in ambulatory diastolic blood pressure [ Time Frame: from baseline (Week 10) to Week 18 ]
  • Change in cuff systolic blood pressure [ Time Frame: from baseline (Week 10) to Week 18 ]
  • Change in cuff diastolic blood pressure [ Time Frame: from baseline (week 10) to Week 18 ]
  • Change in Urinary albumin:creatinine ratio [ Time Frame: from baseline (week 10) to Week 18 ]
  • Change in plasma isoprostanes [ Time Frame: from baseline (week 10) to Week 18 ]
  • Change in urinary nitric oxide metabolites [ Time Frame: from baseline (week 10) to Week 18 ]
  • Change in plasma renin activity [ Time Frame: from baseline (week 10) to Week 18 ]
  • Change in urinary angiotensinogen [ Time Frame: from baseline (week 10) to Week 18 ]
  • Change in non-invasively obtained measures of vascular function [ Time Frame: from baseline (week 10) to Week 18 ]
Same as current
Not Provided
Not Provided
 
Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Hypertension
  • 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
  • Drug: Tekturna(Aliskiren) plus placebo
    Aliskiren 300 mg per day supplemented with placebo
    Other Name: Tekturna (Aliskirin)
  • Active Comparator: Tekturna (Aliskirin) with vit. D supplementation
    Tekturna (Aliskiren) 300mg daily and vitamin D supplementation (50,000 IU)every other week.
    Intervention: Dietary Supplement: Vitamin D (cholecalciferol)
  • Placebo Comparator: Tekturna (Aliskiren) with placebo
    Tekturna (Aliskiren) 300mg per day supplemented with placebo (vitamin D)
    Intervention: Drug: Tekturna(Aliskiren) plus placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
92
March 2014
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01472796
CSPP100AUS41T
Yes
Not Provided
Not Provided
John M. Flack, Wayne State University
Wayne State University
Novartis
Principal Investigator: John M Flack, M.D., M.P.H. Wayne State University, TRaCE Research Group
Wayne State University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP