The Role of Vitamin D in the Pathophysiology of Chronic Failure: Insight in to Mechanisms of Action and Implications for Vitamin D Supplementation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- prevalence of Vitamin D deficiency amongst chronic heart failure patients at the University of Ottawa Heart Institute
研究概览
简要总结
Patients will undergo at baseline and regular intervals:
- clinically indicated bloodwork/urine and echocardiogram testing
- biomarker studies
Upon enrolment in the study patients will be divided into 4 groups normal, mildly deficient and severely deficient. Normal and mild vitamin D levels will receive no treatment while severe Vitamin D deficiency will be randomized (50/50) to receive no treatment or vitamin D treatment. They will be seen in the heart failure clinic every 6 months. The patients will be followed for 26 months.
详细描述
The inclusion criteria for the study is:
- an EF ≤40% within the last 12 months before recruitment
- established diagnosis of heart failure
- >18 years of age
- patients will vitamin d levels of sufficient, mild deficiency and severe deficiency
The exclusion criteria is:
- hypercalcemia
- known hypersensitivity to Vitamin D
- patient unwilling to comply with study requirements
- any other disease other than heart failure that can alter the patients quality of life over a period of 6 months
- women of child bearing potential
- a patient currently taking vitamin d
- severe renal impairment estimated glomerular filtration rate (eGFR) <30
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an ejection fraction (EF) ≤40% within the last 12 months before recruitment
- •established diagnosis of heart failure
- •>18 years of age
- •patients with Vitamin D levels of sufficient, mild deficiency and severe deficiency
排除标准
- •hypercalcemia
- •known hypersensitivity to Vitamin D
- •patient unwilling to comply with study requirements
- •any other disease other than heart failure that can alter the patients quality of life over a period of 6 months
- •women of child bearing potential
- •a patient currently taking vitamin d
- •severe renal impairment eGFR <30
研究组 & 干预措施
Mild Insufficiency
In this arm the participants have a Vitamin D level between 37.5 - 75 ng/ml. The participants will be monitored throughout the study but will receive no intervention.
Severe Deficiency no treatment
In this arm the participants have a low Vitamin D level of less than 37.5 ng/ml. The participants will be monitored but will receive no intervention.
Sufficeint
In this arm the participants have a Vitamin D level of greater than 75 ng/ml. They will continue to be monitored throughout the study but will not receive any intervention.
Severe Deficiency - Treatment
In this arm the participants will be treated with Vitamin D. The participants will be prescribed a dose of 1000 IU a day (1 pill a day). At 6 weeks the dosage will increase to 2000 IU a day (2 pills a day).
干预措施: Vitamin D (Drug)
结局指标
主要结局
prevalence of Vitamin D deficiency amongst chronic heart failure patients at the University of Ottawa Heart Institute
时间窗: up to 3 years
The primary outcome for the study is to identify the prevalence of Vitamin D deficiency amongst chronic heart failure patients followed at the University of Ottawa Heart Institute. This will be done analyzing the Vitamin D blood levels at baseline.
次要结局
- To demonstrate that Vitamin D deficiency is associated with poor outcome and that Vitamin D supplementation can be of clinical benefit(up to 3 years)
研究者
Haissam Haddad
Director Heart Failure Program, Medical Director Heart Transplant Program
Ottawa Heart Institute Research Corporation