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临床试验/NCT00921622
NCT00921622已完成2 期

Vitamin Deficiency and Blood Pressure in Hospitalized JGH Patients

Jewish General Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年6月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
2
主要终点
blood pressure

研究概览

简要总结

There is suggestive evidence that vitamin C and vitamin D deficiency may increase blood pressure across the range of blood pressures from normal to elevated. Information about this relationship is inadequate in part because of the rarity of individuals with subclinical vitamin C and D deficiency. The investigators have observed subnormal to deficient plasma vitamin C and 25-hydroxyvitamin D levels in a large proportion of patients under active treatment in the investigators' hospital. The clinical implications of widespread hypovitaminosis C and D are unknown. In this randomized prospective comparison trial the investigators will measure vitamin levels and blood pressure in clinically stable acutely hospitalized patients with a wide range of diagnoses, and expected to remain in the hospital for at least 7 more days. The investigators will examine for an inverse relationship between baseline vitamin level and blood pressure across the range of blood pressures. Consenting patients will be randomized to receive vitamin C (500 mg twice daily) or vitamin D (1000 IU twice daily) for as long as 10 days. Blood pressure will be re-measured every 2 days and vitamin levels re-measured on the last study day. Treatment courses of at least 5 days will be considered sufficient for analysis. The hypothesis is that either treatment will reduce blood pressure in patients whose baseline systolic blood pressure is 110 or more; the investigators will also examine whether the reduction in blood pressure with treatment is proportional to the increase in the circulating vitamin level with treatment.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Competent to grant informed consent
  • Anticipated to remain in hospital at least 7 days after enrollment

排除标准

  • End-stage renal disease on renal replacement therapy
  • Critical illness
  • Judged unstable clinical status at the time of enrollment

研究组 & 干预措施

Vitamin C

Active Comparator

500 mg twice daily for up to 10 days

干预措施: Vitamin C (Dietary Supplement)

Vitamin D

Active Comparator

1000 IU twice daily for up to 10 days

干预措施: Vitamin C (Dietary Supplement)

Vitamin D

Active Comparator

1000 IU twice daily for up to 10 days

干预措施: Vitamin D (Dietary Supplement)

结局指标

主要结局

blood pressure

时间窗: every 2 days for up to 10 days

次要结局

  • plasma vitamin levels: monitoring variable(at beginning and end of treatment course)

研究者

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

John Hoffer

Physician

Jewish General Hospital

研究点 (2)

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