Vitamin D Deficiency in Patients With Hypertension

UConn Health

Status and phase: Terminated; Phase 4

Conditions: Hypertension; Vitamin D Deficiency

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Cholecalciferol; Drug: Aliskiren

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00974922

20090713 (Other Identifier)

09-166-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 3 patient groups

Phase I: Aliskiren

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Drug: Aliskiren

Phase I: Cholecalciferol

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Cholecalciferol

Phase II: Aliskiren and Vitamin D3

Active Comparator group

Description:

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

Treatment:

Drug: Aliskiren

Dietary Supplement: Cholecalciferol