Clinical trial NCT04805047: SodiUm Restriction by Behavioral Intervention
Official title: Sodium Restriction by Behavioral Intervention: Education and Monitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IgA Nephropathy
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 142
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 24 hour urine protein excretion
timeFrame: 3 months
Secondary outcomes:
measure: 24 hour urine sodium excretion
timeFrame: 3 months
measure: blood pressure
timeFrame: 3 months
measure: estimated Glomerular Filtration Rate change
timeFrame: 3 months
measure: Psychological well-being
timeFrame: 3months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First affiliated hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Huixian Li
role: PRINCIPAL_INVESTIGATOR
References: