A Randomized Placebo-controlled Double Blinded Trial to Evaluate Cholecalciferol (Vitamin D3) and Calcitriol Treatment on Reducing Blood Pressure in Middle Aged Adults With Stage I Hypertension and Vitamin D Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
Vitamin D is a natural nutrient in normal daily diet. It can also be made in the skin after exposure to sunlight and is essential for maintaining normal calcium balance. One past study has suggested that vitamin D may be helpful for blood pressure. This study will test whether pills containing cholecalciferol (a form of vitamin D) or calcitriol (the active form of vitamin D) can treat high blood pressure. The investigators plan to enroll up to 80 subjects at the Atlanta VA Medical Center. Participation in the study is expected to last up to 4 weeks. Subjects will be assigned to cholecalciferol, calcitriol or placebo). A 24-hour blood pressure monitor will be worn at the beginning and end of the study to determine blood pressure changes. Renin, PTH, angiotensin-II, and aldosterone levels will also be measured at the beginning and end of the study.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be over the age of 18
- •Vitamin D levels between 10 and 30 ng/ml
- •Systolic blood pressure between 130 and 150 mmHg
排除标准
- •Current use of anti-hypertensive medication
- •Inability to understand the consent form
- •Inability to return ABP monitor within 24-48 hours after visit
- •Alcohol dependence
- •Diagnosis of chronic kidney disease
- •History of heart disease
- •History of stroke
- •Inability to comply with study protocol
- •Current treatment for cancer
- •Narcotic dependence
- •Current use of greater than 2000 IU of vitamin D
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Cholecalciferol
Cholecalciferol
干预措施: Vitamin D (Drug)
Calcitriol
Calcitriol
干预措施: calcitriol (Drug)
结局指标
主要结局
Blood pressure
时间窗: 3 Weeks
25(OH)D
时间窗: 3 weeks
次要结局
- Parathyroid hormone(3 weeks)
- Renin(3 weeks)
- Aldosterone(3 weeks)
- Angiotensin II(3 weeks)
研究者
Vin Tangpricha
Staff Physician
Atlanta VA Medical Center
