Vitamin D Deficiency in Patients With Hypertension

Vitamin D Deficiency, Renin Inhibitor Response, and Vitamin D Supplementation in Patients With Hypertension

This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who have low levels of vitamin D in their blood. The study will compare the effects of vitamin D or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.

This study will assess whether aliskiren will lower clinic blood pressure and 24-hour blood pressure in patients with hypertension and vitamin D deficiency. Additionally, this study will further explore the potential additional effects of adding vitamin D to aliskiren in this patient population.

Inclusion Criteria:

• Men or women over 21 years of age with a history of Stage 1 or 2 hypertension (defined as a seated diastolic BP ≥ 90 mmHg and < 110 mmHg in the untreated state).
• Patients under treatment for hypertension must be willing and able to discontinue any previous antihypertensive medications for the duration of the study.
• 25-hydroxyvitamin D levels < 30 ng/ml and > 12 ng/ml.
• Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial, must have a negative serum pregnancy test at screening, and must have a negative urine pregnancy test within 7 days before initiating aliskiren therapy.

Exclusion Criteria:

• Vitamin D levels < 12 ng/ml
• Known hypersensitivity or allergy to aliskiren
• Clinic blood pressure > 180/110 mmHg
• Known forms of secondary hypertension
• Chronic atrial fibrillation
• Uncontrolled or unstable cardiovascular diseases
• Shift or night workers
• Mid-arm circumference > 42 cm in diameter
• Current or recent (<1 year) alcohol or drug abuse
• Pregnant or lactating women