Sodium Restriction by Behavioral Intervention: Education and Monitoring
试验速览
- 阶段
- 不适用
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- 24 hour urine protein excretion
研究概览
简要总结
The aim of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with immunoglobulin A nephropathy. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured education program in combination with regular sodium excretion monitoring.
详细描述
Patients in the intervention group receive regular sodium-restriction education by a dietician, which entails introducing food types and cooking skills, quantifying salt intake with a special spoon and recording detailed interactive food diary. Sodium excretion was measured using one 24-hour urine collection regularly to assess dietary compliance and enable feedback. The test persons with sodium excretion higher than 90mmol/24h will receive intensive education. Test persons in the control group receive standard care. After 2 weeks in study, all test persons visit the outpatient clinic for measurements and data collection. Within 3 months of total study duration, data collection and measurements take place at the end of every month.
At each timepoint blood and 24-hourly urine is collected, test persons fill out questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients>14 years of age and <70 years of age
- •Diagnosed immunoglobulin A nephropathy with biopsy;
- •eGFR>30ml/min per 1.73m2 using Chronic Kidney Disease Epidemiology Collaboration formula
- •Proteinuria >1 g per day
- •urinary sodium excretion >200 mmol per day within one month
- •systolic blood pressure higher than 140 mmHg or diastolic blood pressure higher than 90 mmHg, or a well-controlled blood pressure by treatment with antihypertensives including renin-angiotensin-aldosterone system-blockade (ACE-inhibitor or ARB)
- •Written informed consent
排除标准
- •Be treated with diuretics
- •Blood pressure > 180 mmHg systolic or > 125 mmHg diastolic without medical treatment
- •Have undergone renal transplantation
- •With acute kidney injury (RIFLE criteria) < 6 months ago
- •Cardiovascular or cerebrovascular event (myocardial infarction, cerebral hemorrhage or infarction) < 6 months ago
- •With progressive malignancy or pregnancy
- •With contraindications of RAAS blockers
- •unwilling or unable to meet the requirements of the protocol
研究组 & 干预措施
Intervention:education and monitoring
regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback
干预措施: education and monitoring (Behavioral)
control
regular care
结局指标
主要结局
24 hour urine protein excretion
时间窗: 3 months
24 hour urine protein excretion after 3 months
次要结局
- 24 hour urine sodium excretion(3 months)
- blood pressure(3 months)
- estimated Glomerular Filtration Rate change(3 months)
- Psychological well-being(3months)