Vitamin D Deficiency in Patients With Hypertension
- Conditions
- Vitamin D DeficiencyHypertension
- Interventions
- Registration Number
- NCT00974922
- Lead Sponsor
- UConn Health
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase II: Aliskiren and Vitamin D3 Cholecalciferol Aliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks Phase I: Aliskiren Placebo 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 Phase I: Cholecalciferol 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 Phase I: Cholecalciferol Placebo Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Cholecalciferol (3000 I.U.) once daily for 6 weeks Phase I: Aliskiren 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 Phase II: Aliskiren and Vitamin D3 Aliskiren Aliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks
- Primary Outcome Measures
Name Time Method Change From Baseline in Ambulatory Diastolic Blood Pressure six weeks 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.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States