跳至主要内容
临床试验/NCT01896882
NCT01896882Unknown不适用

Effects of Dietary Sodium Restriction in Hemodialysis Patients: Randomized Clinical Trial

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2012年3月最近更新:
适应症
干预措施

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

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

Experimental

Nutritional education on sodium restriction diet.

干预措施: Sodium restriction (Other)

Control

No Intervention

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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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