A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Peak VO2
研究概览
简要总结
The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.
详细描述
The study is designed as a short pilot study which will assess safety and efficacy of high dose Vitamin D therapy in a heart failure population.
A 6 month randomized double blind placebo-controlled trial of 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily vs. weekly placebo plus 800 calcium alone in 64 heart failure (HF) patients > 50 years old. This design was chosen over a cross-over design due to the long wash-out period for vitamin D.
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, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New York Heart Association (NYHA) class II-IV
- •Able to walk
- •Serum 25OHD level 37.5 ng/ml or less
- •Fully titrated on heart failure medications
排除标准
- •Osteoporosis
- •Primary hyperparathyroidism or hypercalcemia.
- •Nephrolithiasis
- •Hemo or peritoneal dialysis and/or creatinine of > 2.5
- •Current use of daily vitamin D greater than 400 IU, corticosteroids, parathyroid hormone (PTH), androgen or estrogen
- •Current illicit drug user or > 3 alcoholic drinks a day
- •Metastatic or advanced cancer
- •Myocardial infarction in the preceding 6 months
- •Medications which can lower vitamin D levels or bioavailability
研究组 & 干预措施
Cholecalciferol
Nutritional supplement
干预措施: Cholecalciferol (Dietary Supplement)
placebo
Weekly placebo plus 800 calcium daily
干预措施: Cholecalciferol (Dietary Supplement)
结局指标
主要结局
Peak VO2
时间窗: change from baseline to 6 months
Cardiopulmonary stress testing with the Peak VO2 representing maximal aerobic capacity
次要结局
- Leg Proximal Muscle Strength(change from baseline to 6 months)
- 6 Minute Walk Distance(Change from baseline to 6 months)
- Timed Get Up and Go(Change from baseline to 6 months)