Vitamin D Deficiency in Patients With Hypertension

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vitamin D Deficiency, Hypertension

Intervention / Treatment
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* Drug: Aliskiren
* Dietary Supplement: Cholecalciferol
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phase I: Aliskiren<br>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 | Drug: Aliskiren<br>* 150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks<br>* Other names: Tekturna;Dietary Supplement: Placebo<br>* Placebo for two weeks<br>|
| Active Comparator: Phase I: Cholecalciferol<br>Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Cholecalciferol (3000 I.U.) once daily for 6 weeks | Dietary Supplement: Cholecalciferol<br>* 3000 I.U. once daily for 6 weeks<br>* Other names: Vitamin D3;Dietary Supplement: Placebo<br>* Placebo for two weeks<br>|
| Active Comparator: Phase II: Aliskiren and Vitamin D3<br>Aliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks | Drug: Aliskiren<br>* 150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks<br>* Other names: Tekturna;Dietary Supplement: Cholecalciferol<br>* 3000 I.U. once daily for 6 weeks<br>* Other names: Vitamin D3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Ambulatory Diastolic Blood Pressure | The primary endpoint was changes from baseline in 24-hour mean diastolic BP on aliskiren versus vitamin D3 in hypertensive patients with vitamin D deficiency. | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Blood Pressure Measurement in 24-hour Systolic BP, Changes in Awake and Sleep Systolic and Diastolic BP, and Changes From Baseline in Clinic Systolic and Diastolic BP. |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Hypertension