SodiUm Restriction by Behavioral Intervention | NCT04805047

Studies
SodiUm Restriction by Behavioral Intervention

NCT04805047

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Unknown status

Last Update Posted

Apr 28, 2022Actual

Enrollment

142Estimated

Phase

Not Applicable

Conditions

IgA Nephropathy

Interventions

education and monitoring

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2021Actual

Primary Completion Date

May 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Mar 17, 2021

First Submission Date that Met QC Criteria

Mar 17, 2021

First Posted Date

Mar 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2022

Last Update Posted Date

Apr 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

142Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention:education and monitoring	Experimental	regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback	Behavioral: education and monitoring
control	No Intervention	regular care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
education and monitoring	Behavioral	regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback	Intervention:education and monitoring

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
24 hour urine sodium excretion	24 hour urine sodium excretion after 3 months	3 months
blood pressure	blood pressure after 3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Huixian Li	Contact	17792905602	17792905602	lihuixian_muye@163.com

Overall Officials

Name	Affiliation	Role
Huixian Li	First Affiliated Hospital Xi'an Jiaotong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First affiliated hospital of Xi'an Jiaotong University	Recruiting	Xi'an	Shaanxi	710061	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38299639	Derived	Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics