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临床试验/NCT00459563
NCT00459563撤回不适用

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

Atlanta VA Medical Center1 个研究点 分布在 1 个国家开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

干预措施: Placebo (Drug)

Cholecalciferol

Active Comparator

Cholecalciferol

干预措施: Vitamin D (Drug)

Calcitriol

Active Comparator

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

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Vin Tangpricha

Staff Physician

Atlanta VA Medical Center

研究点 (1)

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