IgA Nephropathy
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALeducation and monitoring
regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 hour urine protein excretion | 3 months | 24 hour urine protein excretion after 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24 hour urine sodium excretion | 3 months | 24 hour urine sodium excretion after 3 months |
| blood pressure | 3 months | blood pressure after 3 months |
| estimated Glomerular Filtration Rate change | 3 months | estimated Glomerular Filtration Rate change after 3 months |
| Psychological well-being | 3months | Psychological well-being will be assessed with multiple choice questionnaires |
Countries
China
Contacts
Primary ContactHuixian Li
Outcome results
None listed