Back to resultsSodiUm Restriction by Behavioral Intervention (SURBI)
Primary Purpose
IgA Nephropathy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
education and monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for IgA Nephropathy
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
Sites / Locations
- First affiliated hospital of Xi'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention:education and monitoring
control
Arm Description
regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback
regular care
Outcomes
Primary Outcome Measures
24 hour urine protein excretion
24 hour urine protein excretion after 3 months
Secondary Outcome Measures
24 hour urine sodium excretion
24 hour urine sodium excretion after 3 months
blood pressure
blood pressure after 3 months
estimated Glomerular Filtration Rate change
estimated Glomerular Filtration Rate change after 3 months
Psychological well-being
Psychological well-being will be assessed with multiple choice questionnaires
Full Information
NCT ID
NCT04805047
First Posted
March 17, 2021
Last Updated
April 26, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT04805047
Brief Title
SodiUm Restriction by Behavioral Intervention
Acronym
SURBI
Official Title
Sodium Restriction by Behavioral Intervention: Education and Monitoring
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention:education and monitoring
Arm Type
Experimental
Arm Description
regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback
Arm Title
control
Arm Type
No Intervention
Arm Description
regular care
Intervention Type
Behavioral
Intervention Name(s)
education and monitoring
Intervention Description
regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback
Primary Outcome Measure Information:
Title
24 hour urine protein excretion
Description
24 hour urine protein excretion after 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
24 hour urine sodium excretion
Description
24 hour urine sodium excretion after 3 months
Time Frame
3 months
Title
blood pressure
Description
blood pressure after 3 months
Time Frame
3 months
Title
estimated Glomerular Filtration Rate change
Description
estimated Glomerular Filtration Rate change after 3 months
Time Frame
3 months
Title
Psychological well-being
Description
Psychological well-being will be assessed with multiple choice questionnaires
Time Frame
3months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huixian Li
Phone
17792905602
Ext
17792905602
Email
lihuixian_muye@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huixian Li
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First affiliated hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huixian Li, Master
Phone
18691636705
Email
lihuixian_muye@163.com
12. IPD Sharing Statement
Learn more about this trial
SodiUm Restriction by Behavioral Intervention
We'll reach out to this number within 24 hrs