Vitamin D Deficiency in Patients With Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-12-31

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.

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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.

Conditions

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Vitamin D Deficiency Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Phase I: Aliskiren

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

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type DRUG

150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo for two weeks

Phase I: Cholecalciferol

Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Cholecalciferol (3000 I.U.) once daily for 6 weeks

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

3000 I.U. once daily for 6 weeks

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo for two weeks

Phase II: Aliskiren and Vitamin D3

Aliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks

Group Type ACTIVE_COMPARATOR

Aliskiren

Intervention Type DRUG

150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

3000 I.U. once daily for 6 weeks

Interventions

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Aliskiren

150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks

Intervention Type DRUG

Cholecalciferol

3000 I.U. once daily for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo for two weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Tekturna Vitamin D3

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No