SodiUm Restriction by Behavioral Intervention (SURBI)

April 26, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

Sodium Restriction by Behavioral Intervention: Education and Monitoring

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention:education and monitoring
regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback
Behavioral: education and monitoring
regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback
No Intervention: control
regular care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour urine protein excretion
Time Frame: 3 months
24 hour urine protein excretion after 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour urine sodium excretion
Time Frame: 3 months
24 hour urine sodium excretion after 3 months
3 months
blood pressure
Time Frame: 3 months
blood pressure after 3 months
3 months
estimated Glomerular Filtration Rate change
Time Frame: 3 months
estimated Glomerular Filtration Rate change after 3 months
3 months
Psychological well-being
Time Frame: 3months
Psychological well-being will be assessed with multiple choice questionnaires
3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Huixian Li, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2020LSK-073

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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