SodiUm Restriction by Behavioral Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sodium Restriction by Behavioral Intervention: Education and Monitoring

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Behavioral: education and monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention:education and monitoring<br>regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback | Behavioral: education and monitoring<br>* regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback<br>|
| No Intervention: control<br>regular care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour urine protein excretion | 24 hour urine protein excretion after 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour urine sodium excretion | 24 hour urine sodium excretion after 3 months | 3 months | 
| blood pressure | blood pressure after 3 months | 3 months | 
| estimated Glomerular Filtration Rate change | estimated Glomerular Filtration Rate change after 3 months | 3 months | 
| Psychological well-being | Psychological well-being will be assessed with multiple choice questionnaires | 3months |