Effects of Dietary Sodium Restriction in Hemodialysis Patients: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Sodium intake
研究概览
简要总结
Excess dietary sodium can lead to poor outcomes, such as hypertension, edema and increased risk for cardiovascular diseases. These complications are associated with end stage renal disease (ESRD) progression and mortality in renal patients. This study aims to evaluate the effects of nutritional counseling restricting dietary sodium and its relation to clinical and diet factors, nutritional knowledge and quality of life in hemodialysis patients.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical stable patients on dialysis for at least 3 months, over 18 years old, of both sexes, who agree to participate in the study.
排除标准
- •Patients with low cognitive ability, psychiatric disorders, with acute or infectious disease.
研究组 & 干预措施
Intervention
Nutritional education on sodium restriction diet.
干预措施: Sodium restriction (Other)
Control
Standard treatment.
结局指标
主要结局
Sodium intake
时间窗: Baseline, 30, 90, 180 and 360 days
Sodium intake will be evaluated by food record and a food frequency questionnaire.
Quality of life
时间窗: Baseline, 180 and 360 days.
Quality of life will be evaluated by the Brazilian Portuguese version of the Kidney Disease and Quality-of-Life Short-Form (KDQOL-SF) questionnaire.
次要结局
- Interdialytic weight gain(Baseline, 30, 90, 180 and 360 days.)
