SodiUm Restriction by Behavioral Intevention

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Brief Title

SodiUm Restriction by Behavioral Intervention

Official Title

Sodium Restriction by Behavioral Intervention: Education and Monitoring

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.
    


Study Type

Interventional


Primary Outcome

24 hour urine protein excretion

Secondary Outcome

 24 hour urine sodium excretion

Condition

IgA Nephropathy

Intervention

education and monitoring

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

142

Start Date

May 15, 2021

Completion Date

December 2023

Primary Completion Date

May 2023

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
      

Gender

All

Ages

14 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Huixian Li, 17792905602, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04805047

Organization ID

XJTU1AF2020LSK-073


Responsible Party

Sponsor

Study Sponsor

First Affiliated Hospital Xi'an Jiaotong University


Study Sponsor

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


Verification Date

September 2021