The Effect of Calcium and Vitamin D in Patients With Heart Failure
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
- 否
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
Calcium and vitamin D
干预措施: Vitamin D (Drug)
2
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
Louise Lind Schierbeck
MD, research fellow
Hvidovre University Hospital
