Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 30 - 74 |
| Updated: | 4/2/2016 |
| Start Date: | July 2011 |
| End Date: | March 2014 |
| Contact: | Carol A Muzyk, CCRP |
| Email: | cmuzyk@med.wayne.edu |
| Phone: | 313-745-2378 |
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.
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.
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.
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
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