SodiUm Restriction by Behavioral Intervention (SURBI)

Xi'an Jiaotong University

Status

Unknown

Conditions

IgA Nephropathy

Treatments

Behavioral: education and monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT04805047

XJTU1AF2020LSK-073

Details and patient eligibility

About

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.

Full 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.

Enrollment

142 estimated patients

Sex

All

Ages

14 to 70 years old

Volunteers

No Healthy Volunteers

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