Vitamin C Supplementation Intervention for Patients With Heart Failure-A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Serum Vitamin C Level at Baseline
研究概览
简要总结
This study is to test a low-cost, simple vitamin C supplementation intervention, that is, comparing placebo to 500 mg/day vitamin C and 1 gram/day vitamin C daily to assess feasibility and acceptability of vitamin C supplementation and effects on serum vitamin C level, health-related quality of life (HRQOL), symptom burden, oxidative stress, and cardiac function.
详细描述
This study will address feasibility from the perspective of being able to: a) to detect significant differences in the serum vitamin C level after supplementation (3 months) between the intervention groups and the control group, b) to detect significant differences in health related quality of life (HRQOL), symptom burden, oxidative stress, and cardiac function after vitamin C supplementation (3 months) between the intervention groups and the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patents recruited will have a diagnosis of chronic HF, either preserved or reduced ejection fraction. The diagnosis and etiology of chronic HF will be confirmed by a HF cardiologist using established criteria.
- •Other criteria:
- •have undergone evaluation of HF and optimization of medical therapy,
- •vitamin C supplementation <500 mg/day
- •have not been referred for heart transplantation,
- •able to read and speak English,
- •>1 month from any inpatient hospitalization
排除标准
- •history of renal stones or renal disease (serum creatinine >1.5,
- •history of glucose-6-phosphate dehydrogenase deficiency (G6PD) and cognitive impairment that precludes giving informed consent or ability to follow protocol instructions
结局指标
主要结局
Serum Vitamin C Level at Baseline
时间窗: Baseline
The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum
Serum Vitamin C Level at Month 3
时间窗: Month 3
The ELISA (enzyme-linked immunosorbent assay) used to detect and quantify Vitamin C in serum
次要结局
- Total MSAS-HF Score(Baseline and up to 3 months after enrollment)
- Health Related Quality of Life Scores(Baseline and up to 3 months after enrollment)
- Cardiac Function(Baseline and up to 3 months after enrollment)
- Oxidative Stress(Baseline and up to 3 months after enrollment)