Supplementation With Vitamin D to Patients With Heart Failure. Effects on Symptoms, Quality-of-life and Disease Processes.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Reduction in the composite endpoint for heart failure
研究概览
简要总结
In 200 patients with documented systolic heart failure give supplementation with vitamin D in those with a 25-OH- vitamin D < 50nmol/L - or placebo.
In those with a vitamin D level <25nmol/L a substitution of 2400IU will be given, and in those with a vitamin D level 25-50nmol/L a substitution of 1600IU will be given.
Intervention time 12 months. Biomarkers of heart function, quality of life, and hospitalisation will be analysed.
详细描述
In a population with a systolic heart failure with an EF<40%, the levels of vitamin D will be analysed. In those with a 25-OH-vitamin D level <50nmol/L the patients that accept participation, will be randomised into active supplementation as described below, or placebo.
- In those with a 25-OH-vitamin D level <25nmol/L there will be a supplementation of 2400IU daily
- In those with a vitamin D level 25-50nmol/L there will be a supplementation of 1600IU daily,
- or placebo. Thus based on the basal level of vitamin D the screened patients will either be excluded due to high level of vitamin D, or given one ot the two options of vitamin D dosage based on the basal patient level - or placebo.
The intervention time will be 12 months. In the project 200 heart failure patients will be included. Blood samples including heart failure biomarkers, and biomarkers for inflammation and oxidative stress will be drawn at 3,6, 9 and 12 months.
Health related quality of life will be evaluated by use of Euro-QoL-5D Minnesota Living with Heart Failure.Patient Health Questionnaire-9 Multidimensional Fatigue Inventory 20 questionnaire, as also hospitalisation during the project time.
Cardiac function according to echocardiography will be analysed at start, and study end.
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, Care Provider)
盲法说明
Neither the participant, nor the care provider will be informed if active supplementation or placebo will be given, nor will blood sample results be open for care provider
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented and stable systolic heart failure and connected to an outpatient clinic at the Dept of Cardiology in Linköping, or Jönköping, Sweden, and with a 25-OH-vitamin D <50nmol/L
排除标准
- •Patients with unstable heart failure
- •Patients with significant valvular disease, or ischemic heart disease planned for operation
- •Patients with significant renal or /and liver impairment.
- •Patients that do not understand that study information, or that are not willing to participate
研究组 & 干预措施
Placebo
In the group randomised to placebo and with a screening level of 25-OH-vitamin D <50 mol/L, the participants will be given placebo.
干预措施: Vitamin D (Dietary Supplement)
Active intervention
In the group randomised to active treatment and with a screening level of 25-OH-vitamin D 25-50nmol/L an intervention with 1600IE daily of vitamin D will be given.
In those randomised to active treatment and with a screening level of 25-OH-vitamin D of <25nmol/L, an intervention of 2400IE of vitamin D will be given.
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Reduction in the composite endpoint for heart failure
时间窗: Follow-up 12 months after stop of intervention
Reduction in biomarkers for heart failure(Nt-proBNP, Copeptin, MR-proADM and Chromogranin A) and in hospitalisation that comprised the composite endpoint
次要结局
- Influence on quality of life in patients with heart failure by the intervention(Follow-up 12 months after stop of intervention)
研究者
Urban Alehagen
Professor, MD.
Linkoeping University