跳至主要内容
临床试验/NCT00497900
NCT00497900已完成4 期

The Effect of Calcium and Vitamin D in Patients With Heart Failure

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
45
试验地点
1
主要终点
Ejection fraction

研究概览

简要总结

Previous studies have shown high proportions of vitamin D deficiency among elderly in Denmark. Vitamin D is important for muscular function. The investigators intend to examine if it is possible to improve cardiovascular function in patients with heart failure and vitamin D deficiency by supplementation with vitamin D.

详细描述

Heart failure (HF) is a major course of morbidity and mortality. The prevalence in the Danish population is 1-2% and for age 50 -75 years: 2-3% (1) . It has been estimated that there are currently 6.5 million HF patients in Europe and 5 million in the USA (2) . Lack of vitamin D has been linked to heart disease including ischemic heart disease, heart failure, and hypertension.(3) Vitamin D deficiency is prevalent in the elderly population. Calcium absorption, bone mineralization and muscle function may be impaired. Vitamin D receptors have also been demonstrated in skeletal as well as cardiac muscle(4) . Vitamin D and Parathyroid Hormone (PTH) are closely linked in the calcium metabolic system. In order to maintain serum calcium within range PTH and vitamin D acts together in response to changes in serum-calcium levels. 25(OH)D concentration also being an important factor determining the levels of PTH.(5) Decreasing vitamin D leads to increasing levels of PTH. Hyperparathyroidism in patients with kidney-disease has in numerous studies been linked to cardiovascular disease, left ventricle hypertrophy, and valvular calcification .(6) Aim: Intervention with vitamin D and calcium will improve patients' vitamin D levels and suppress PTH. Thus we hope to find an improved cardiac function and quality of life in the intervention-group.

Comparison: Cardiac function (and other effect parameters - such as self-evaluated health) in the intervention group vs. in the placebo-group

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
Triple (Participant, 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

入选标准

  • Over 18 years of age
  • Vitamin D (serum 25-OHD): 50nmol/l or less
  • Heart failure (EF 40% or less, NYHA:2 or more)

排除标准

  • Calcium metabolic disturbances
  • Granulomatous diseases
  • Alcohol or drug abuse
  • Intake of 400IU (or more) vitamin D/day
  • Condition too poor to participate
  • Pregnancy
  • AF with HF 90 or above
  • Mitral insufficiency, degree 3 or above
  • Large cardiac aneurisms
  • Significant aorta stenosis
  • Significant aorta insufficiency
  • Allergy to components

研究组 & 干预措施

1

Experimental

Calcium and vitamin D

干预措施: Vitamin D (Drug)

2

Placebo Comparator

Calcium and placebo (cellulose)

干预措施: Vitamin D (Drug)

结局指标

主要结局

Ejection fraction

时间窗: 6 months

次要结局

  • Biochemical markers(6 months)
  • Quality of life(6 months)
  • 6 minutes walk test(6 months)

研究者

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

Louise Lind Schierbeck

MD, research fellow

Hvidovre University Hospital

研究点 (1)

Loading locations...

相似试验

The Effect of Calcium and Vitamin D in Patients With... | 临床试验