SodiUm Restriction by Behavioral Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sodium Diet Effect on Aldosterone and Urinary RNA (SALTY)

NCT04168073

Healthy

COMPLETED NA

Effects of Intensive Low-Salt Diet Education by Mobile Application on Albuminuria

NCT03396328

Albuminuria

COMPLETED NA

Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia

NCT01507727

Non-hypovolemic Non-acute Hyponatremia

UNKNOWN PHASE2/PHASE3

Dietary Sodium Restriction in Hemodialysis Patients

NCT01896882

Hemodialysis Patients

UNKNOWN NA

Sodium Lowering and Urinary Protein Reduction Trial

NCT02945969

Chronic Kidney Disease Albuminuria

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

IgA Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention:education and monitoring

regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback

Group Type EXPERIMENTAL

education and monitoring

Intervention Type BEHAVIORAL

regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback

control

regular care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

education and monitoring

regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No