Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SodiUm Restriction by Behavioral Intervention (SURBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04805047
Recruitment Status : Recruiting
First Posted : March 18, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Behavioral: education and monitoring Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sodium Restriction by Behavioral Intervention: Education and Monitoring
Actual Study Start Date : May 15, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 24 hour urine protein excretion [ Time Frame: 3 months ]
    24 hour urine protein excretion after 3 months


Secondary Outcome Measures :
  1. 24 hour urine sodium excretion [ Time Frame: 3 months ]
    24 hour urine sodium excretion after 3 months

  2. blood pressure [ Time Frame: 3 months ]
    blood pressure after 3 months

  3. estimated Glomerular Filtration Rate change [ Time Frame: 3 months ]
    estimated Glomerular Filtration Rate change after 3 months

  4. Psychological well-being [ Time Frame: 3months ]
    Psychological well-being will be assessed with multiple choice questionnaires


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805047


Contacts
Layout table for location contacts
Contact: Huixian Li 17792905602 ext 17792905602 lihuixian_muye@163.com

Locations
Layout table for location information
China, Shaanxi
First affiliated hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Huixian Li, Master    18691636705    lihuixian_muye@163.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
Layout table for investigator information
Principal Investigator: Huixian Li First Affiliated Hospital Xi'an Jiaotong University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT04805047    
Other Study ID Numbers: XJTU1AF2020LSK-073
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glomerulonephritis, IGA
Kidney Diseases
Urologic Diseases
Glomerulonephritis
 Nephritis
Autoimmune Diseases
Immune System Diseases