Increased Low-potassium Content Vegetables Consumption in Patients With Moderate-to-severe Chronic Kidney Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Percentage of participants who reach the targets of daily vegetable recommended target
研究概览
简要总结
Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. Thus, the investigators aim to evaluate whether proving low-potassium content vegetables to this population are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.
详细描述
Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. According to the suggestions from 2018 Ministry of Health and Welfare in Taiwan, vegetables intake are at least 3 to 5 servings daily based on the daily energy requirement. In our own data, the average daily vegetables intake was only 2.1 servings among patients with CKD stages 3 to 5 not yet on dialysis. Therefore, the investigators aim to evaluate whether proving low-potassium content vegetables to patients with CKD stages 3 to 5 not yet on dialysis are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.
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
- None
盲法说明
Masking is not allowed in this study
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD stage 3b~5, not yet on dialysis
- •Age ≥20 years
- •Stable doses of medications for 4 weeks
- •Serum potassium level: ≥3.5 and < 5.5 mmol/L
排除标准
- •Anticipated to receive dialysis within 3 month
- •Major gastrointestinal diseases (inflammatory bowel disease, celiac disease) or intestinal resection
- •Patients with infection, malignancy, heart failure, liver cirrhosis or impaired cognitive or mental disorders
- •Patients who are just hospitalized due to an acute cardiovascular events or infection 3 months prior to the start of study
- •Patients with kidney transplants
- •Patients who receive immunosuppressant
- •Pregnant women or patients who are planning to become pregnant
结局指标
主要结局
Percentage of participants who reach the targets of daily vegetable recommended target
时间窗: 8 weeks
Percentage of participants who reach the targets of daily vegetable recommended
次要结局
- Occurrence of moderate hyperkalemia(8 weeks)
- Gut microbiome(8 weeks)
- Proteinuria(8 weeks)
- Gut-derived uremic toxins(8 weeks)
- Serum creatinine(8 weeks)
- Status of constipation(8 weeks)
研究者
Szu-Chun Hung
Professor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation