Vitamin D Deficiency, Renin Inhibitor Response, and Vitamin D Supplementation in Patients With Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change From Baseline in Ambulatory Diastolic Blood Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Aliskiren (Drug)
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
干预措施: Placebo (Dietary Supplement)
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
干预措施: Cholecalciferol (Dietary Supplement)
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
干预措施: Placebo (Dietary Supplement)
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
干预措施: Aliskiren (Drug)
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
干预措施: Cholecalciferol (Dietary Supplement)
结局指标
主要结局
Change From Baseline in Ambulatory Diastolic Blood Pressure
时间窗: 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.
次要结局
- 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)
研究者
William B. White
Professor of Medicine
UConn Health