Styrian Vitamin D Hypertension Trial: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Systolic Ambulatory Blood Pressure in Vitamin D Deficient Hypertensive Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 24-hour systolic ambulatory blood pressure
研究概览
简要总结
In this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin D deficient hypertensive patients. Our main objective is to evaluate whether vitamin D3 supplementation with 2,800 IU daily for 8 weeks has an effect on 24-hour systolic ambulatory blood pressure (ABP) compared to placebo. In addition, we also aim to evaluate whether vitamin D3 supplementation alters 24-hour diastolic ABP, pulse wave velocity, N-terminal-pro-brain natriuretic peptide (NT-pro-BNP), corrected QT interval (Bazett formula), renin, aldosterone, 24-hour urinary albumin excretion, HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance), triglycerides and HDL-cholesterol.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25-hydroxyvitamin D levels below 30 ng/ml (75 nmol/L)
- •Arterial hypertension defined according to recent guidelines as an average office blood pressure on at least two occasions of systolic ≥ 140 and/or diastolic ≥ 90 mmHg or a mean 24-hour ABP of systolic ≥ 125 and/or diastolic ≥ 80, or a home blood pressure of systolic ≥ 130 and/or diastolic ≥ 85 or ongoing antihypertensive treatment which was initiated due to arterial hypertension
- •Age of ≥ 18 years
- •Written informed consent.
排除标准
- •Hypercalcemia defined a serum calcium >2.65 mmol/L
- •Pregnancy or lactating women
- •Drug intake as part of another clinical study
- •Acute coronary syndrome or cerebrovascular events in the previous 2 weeks
- •Glomerular filtration rate (GFR) according to the MDRD formula < 15 ml/min/1.73m²
- •Systolic 24-hour ABP > 160 mm Hg or < 120 mm Hg
- •Diastolic 24-hour ABP > 100 mm Hg
- •Change of antihypertensive treatment (drugs and/or lifestyle) in the previous 4 weeks or planned changes of antihypertensive treatment during the study
- •Any disease with an estimated life expectancy below 1 year
- •Any clinically significant acute disease requiring drug treatment
- •Chemotherapy or radiation therapy during the study
- •Regular intake of more than 880 International Units (IU) vitamin D per day in the last four weeks before study entry or during the study
研究组 & 干预措施
Placebo
Oily drops as placebo
干预措施: Placebo (Dietary Supplement)
Vitamin D3
The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3; producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
24-hour systolic ambulatory blood pressure
时间窗: 8 weeks
次要结局
- 24-hour diastolic ambulatory blood pressure(8 weeks)
- N-terminal-pro-brain natriuretic peptide (NT-pro-BNP)(8 weeks)
- 24-hour urinary albumin excretion(8 weeks)
- corrected QT interval (Bazett formula)(8 weeks)
- Triglycerides(8 weeks)
- HDL-cholesterol(8 weeks)
- Pulse wave velocity(8 weeks)
- Renin(8 weeks)
- Aldosterone(8 weeks)
- HOMA-IR(8 weeks)