SodiUm Restriction by Behavioral Intervention

Not Applicable

• Conditions: IgA Nephropathy
• Interventions: Behavioral: education and monitoring

• Registration Number: NCT04805047
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-18
• Study Start: 2021-05-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-28
• Primary Completion: 2023-05
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention:education and monitoring	education and monitoring	regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback

Primary Outcome Measures

Name	Time	Method
24 hour urine protein excretion	3 months	24 hour urine protein excretion after 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

First affiliated hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China