Double-Blind, Placebo-Controlled Trial of Vitamin D3 (Cholecalciferol) Supplementation for Heart Failure Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- B type Natriuretic Peptide (BNP)
研究概览
简要总结
The purpose of this study is to determine if treatment with vitamin D3 of 10,000 International Units (IU) daily in vitamin D deficient patients for 6 months will improve B type natriuretic peptide (BNP), a marker of heart function, compared to placebo. The investigators also aim to determine if vitamin D helps cardiopulmonary function as evaluated by cardiopulmonary exercise test (CPX), laboratory values, strength, and quality of life in patients with stable congestive heart failure (Class II or III).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NYHA Heart Failure Class II or II, stable
- •Vitamin D deficiency (32 ng/ml or less)
- •No recent medication changes for 3 months
- •Females of childbearing age must use effective contraceptive if they are sexually active
排除标准
- •Hypercalcemia
- •Nephrolithiases
- •Sarcoidosis
- •Acute cardiac insufficiency
- •Pregnancy
- •Breastfeeding
- •Any clinically unstable medical condition
- •Supplements of greater than or equal to 1000 units of vitamin D per day
研究组 & 干预措施
Vitamin D3 (cholecalciferol)
10,000 International Units of vitamin D3 will be given daily for 6 months in vitamin D deficient heart failure patients.
干预措施: Vitamin D3 (cholecalciferol) (Drug)
结局指标
主要结局
B type Natriuretic Peptide (BNP)
时间窗: Change in BNP will be measured at baseline and after 6 months of treatment with vitamin D or placebo
BNP is a hormone secreted by the heart ventricles, and high concentrations of this hormone occur in heart failure. It is a strong prognostic indicator.
次要结局
- Cardiopulmonary exercise test (CPX)(Change in CPX will be measured at baseline and after 6 months of treatment with Vitamin D3 or placebo)
- 25 hydroxyvitamin D [25 (OH)D](Change in 25 hydroxyvitamin D will be measured at baseline, at 12 weeks, and after 6 months of treatment with vitamin D or placebo)
- C reactive protein (CRP)(Change in CRP will be measured at baseline and after 6 months of treatment with vitamin D or placebo)
- Serum Calcium(Change in serum calcium levels will be measured at baseline, at 12 weeks, and at 6 months of treatment with vitamin D or placebo)
- 6 minute walk test(Change in the 6 minute walk test will be measured at baseline and at 6 months of treatment with vitamin D or placebo)
- Kansas City Cardiomyopathy Questionnaire(Chang in the KCCQ will be measured at baseline and after 6 months of treatment with vitamin D or placebo)
研究者
Heidi Moretti, MS, RD
Co-Investigator
Saint Patrick Hospital