Conditions: Vitamin D Deficiency Hypertension
Keywords: Vitamin D Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Aliskiren 150 mg to 300 mg once daily for 6 weeks arm 2: Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Cholecalciferol (3000 I.U.) once daily for 6 weeks arm 3: Aliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks

Interventions: intervention 1: Aliskiren intervention 2: Cholecalciferol intervention 3: Placebo
Intervention descriptions: intervention 1: 150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks intervention 2: 3000 I.U. once daily for 6 weeks intervention 3: Placebo for two weeks

Protocol document: