SodiUm Restriction by Behavioral Intervention

IgA Nephropathy Clinical Trial

— SURBI  

Official title:

Sodium Restriction by Behavioral Intervention: Education and Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805047
• Other study ID #: XJTU1AF2020LSK-073
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Huixian Li
• Phone: 17792905602
• Email: lihuixian_muye[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: December 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy

Intervention

Behavioral:
• education and monitoring
regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback

Locations

Country	Name	City	State
China	First affiliated hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour urine protein excretion	24 hour urine protein excretion after 3 months	3 months
Secondary	24 hour urine sodium excretion	24 hour urine sodium excretion after 3 months	3 months
Secondary	blood pressure	blood pressure after 3 months	3 months
Secondary	estimated Glomerular Filtration Rate change	estimated Glomerular Filtration Rate change after 3 months	3 months
Secondary	Psychological well-being	Psychological well-being will be assessed with multiple choice questionnaires	3months