Status:
UNKNOWN
Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension
Lead Sponsor:
Wayne State University
Collaborating Sponsors:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
30-74 years
Phase:
PHASE4
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 funct...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01472796
Start Date
July 1 2011
End Date
March 1 2014
Last Update
November 16 2011
Active Locations (1)
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1
Wayne State University, 4201 St. Antoine
Detroit, Michigan, United States, 48201