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临床试验/NCT02047799
NCT02047799已完成2 期

Effect of Vitamin D Supplementation on Blood Pressure in Elderly People

Universidad de Colima2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2013年4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
45
试验地点
2
主要终点
Difference of systolic and diastolic blood pressure

研究概览

简要总结

The prevalence and incidence of cardiovascular disease (such as Hypertension) increases exponentially with age (McDermott, 2007;) These diseases account for 30% of the global mortality (WHO, 2011). Vitamin D (VD) insufficiency affects as many as half of otherwise healthy adults in developed countries (Holick, 2007). VD is implicated in the control of blood pressure (BP) through inhibition of the renin-angiotensin system (Yamshchikov, 2009), although the role of VD supplementation for prevention and treatment of the HTA is controversial.The purpose of this study was to investigate if VD supplement in elderly people reduces the levels of BP.

详细描述

Study population Adults aged ≥ 60 years with essential hypertension were recruited through nursing homes and physical activity groups in the state of Colima, México. 45 subjects were assessed for eligibility at our out-patient clinic. We excluded subjects with impaired renal or hepatic function; also subjects who had been treated with vitamin D within the last three months.

None were on hormone replacement therapy, but we included subjects on anti-hypertensive for more than 10 years and the dosages were unchanged during the study. Before randomization, two subjects withdrew the informed consent because of personal reasons, and two subjects were excluded due to the diagnosis of severe hypertension.

Design The design was a double-blind, placebo controlled randomized clinical trial. The participants were randomly assigned using a computer-generated randomization code into two groups: group 1 (calcitriol group)with 22 subjects whom were enrolled for 6 weeks of treatment with a daily dose of 1000 IU of cholecalciferol (administered as 1 capsule of 25 μg each) and group 2 with 23 subjects (control group) whom received a similar placebo tablet for also 6 weeks.

During treatment, nine subjects (20%) left the trial due to personal reasons. All patients provided written informed consent. The study was conducted in accordance with the Declaration of Helsinki II and the guidance on Good Clinical Practice (GCP). Approval was obtained from the bioethics committee of the Faculty of Medicine from the University of Colima (FM014/2012).

Measurement At the screening visit prior to randomization, subjects had a routine clinical examination and data concerning medical history. BP was measured 3 consecutive days at the same time, using a kit integrated aneroid sphygmomanometer with stethoscope (medimetrics 5769) with the patient seated and with at least 5 min rest. The subjects with average BP >140/90 mm Hg were included in 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
Double (Participant, Investigator)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged ≥ 60 years with essential hypertension.
  • Subjects on anti-hypertensive for more than 10 years and the dosages were unchanged during the study.

排除标准

  • Subjects who had been treated with vitamin D within the last three months.
  • None were on hormone replacement therapy.

研究组 & 干预措施

Control

Placebo Comparator

A daily dose of placebo (administered as 1 capsule )

干预措施: Control (Dietary Supplement)

Calcitriol

Active Comparator

A daily dose of 1000 IU of cholecalciferol (administered as 1 capsule of 25 μg each)

干预措施: Calcitriol (Dietary Supplement)

结局指标

主要结局

Difference of systolic and diastolic blood pressure

时间窗: 6 weeks

Difference between systolic and diastolic blood pressure before and after treatment.

次要结局

  • Difference of Serum 25-Hidroxyvitamin-D(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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