Phase 4 Study of 25-hydroxy-vitamin D in Patients With Peripheral Artery Occlusive Disease and Walking Ability
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change from baseline absolute claudication distance (ACD) at 3 months
研究概览
简要总结
The purpose of this study is to determine whether the intake of Vitamin D has a positive effect on walking ability of patients with peripheral artery occlusive disease. Skeletal muscle fibers change morphology in peripheral artery occlusive disease. In patients with Vitamin D-deficiency there are also changes of skeletal muscle fibers. The investigators have the hypothesis that patients with peripheral artery occlusive disease with subsequent changes of muscle fibers morphology of calf muscles might take profit of the administration of Vitamin D in combination with training.
详细描述
Background On the one hand, patients suffering from peripheral artery occlusive disease may have a significant decrease in their walking ability. When there is insufficient supply of oxygen to the muscles, especially the calf muscles, structural changes of skeletal muscle fibers appear. On the other hand, these patients might also have an insufficient supply with Vitamin D as it is often the case in the general population. A deficiency of Vitamin D also causes structural changes in the skeletal muscles and causes muscle weakness.
Hypothesis Vitamin D - intake can improve the walking ability of patients with peripheral artery occlusive disease and eventually Vitamin D - deficiency.
Aim of the study To evaluate the influence of Vitamin D - intake on walking ability of patients with peripheral artery occlusive disease, which would be a simple, safe and non-invasive measure with a positive effect on quality of life and indirectly on cardiovascular health in general (better mobility).
Primary endpoint:
Measurement of walking ability with treadmill test at the beginning and after a 3 month-treatment with Vitamin D, in combination with a home-based training.
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, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •peripheral artery obliterative disease Rutherford 1 to 3
- •informed consent
- •motivation
排除标准
- •inability of treadmill walking
- •not motivated
- •female patients: childbearing age (age limit 49 years)
- •PTA or surgical revascularisation within 3 months before study entry
- •cancer, life expectancy lower than 6 months
- •ongoing therapy with Vitamin D
- •25-OH-Vitamin D level 125 nmol/l and above
- •contraindications for Vitamin D intake (sarcoidosis, acute lung tbc, hypercalcemia, intake of Vitamin D analogs
- •contraindications for ultrasound contrast agent (known hypersensitivity, recent acute coronary syndrome, unstable ischemic heart disease, after PTCA, heart insufficiency NYHA III or IV, severe rhythm disorders, known right- left shunt, severe pulmonary artery hypertension, adult respiratory distress syndrome
研究组 & 干预措施
Vitamin D
干预措施: Cholecalciferol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline absolute claudication distance (ACD) at 3 months
时间窗: 3 months
Follow up after 6 months.
Change from baseline initial claudication distance (ICD) at 3 months
时间窗: 3 months
Follow up after 6 months.
次要结局
- Change from baseline Vitamin D3 at 3 months(3 months)
- Change of baseline Calcium at 3 months(3 months)