- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02519894
Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
Introduction :
Due to Chronic kidney disease is a public health problem, which is important increased in both developed and developing countries . And sodium intake restriction was related to the reduction of blood pressure and urine protein which is one of the important risk factor in chronic kidney disease. One of the problem in sodium restriction failure in Thai population with CKD nowadays is lack of knowledge and problem unawareness.
The study hypothesis :
Intense knowledge about sodium reduction and immediate feedback of the sodium intake could be simultaneously modifying the behavior to reduce sodium intake , blood pressure and also GFR reduction rate
Objectives :
To compare the effect of dietary salt restriction on glomerular filtration rate (GFR) between CKD patients receiving strict controlled combined with immediate individual feedback (DISC Progrram) and those receiving standard education.
Study design :
Multicenter, open labeled, parallel, randomized controlled trial
Sample size : 600
Primary outcome : GFR reduction (CKD-EPI)
Secondary outcome :
- Achievement rate of Na intake < 2 g/day (Urine Na < 90 mEq/day)
- Blood pressure difference
- Proportions of patients with BP reached the target (130/80 mmHg)
- Number of anti-hypertensive drugs use to achieve BP target
- Urine albumin/creatinine ratio
- Major Adverse Cardiac Events (MACE)
- Cardio-ankle vascular index (CAVI)
- ankle-brachial index (ABI)
Documentary Proof of Ethical Clearance :
This project has been reviewed and approved by the Comittee on Human Rights Related to Research Involving Human Subjects , based on the declaration of Helsinki
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- CKD stage 3-4 (eGFR 15-59 mL/min/1.73m²)
- Microalbuminuria
- Any blood pressure level
Exclusion Criteria:
- Salt - losing conditions
- Hyponatremia (Na < 135 mg/dL) or Hypernatremia (Na > 145 mg/dL)
- Bilateral renal artery stenosis
- Severe comorbid disease or life expectancy <1 year (severe cardiovascular disease, chronic liver disease, severe infection , malignancy)
- Immunosuppressant used
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Intensive low sodium education and immediate sodium intake feedback by dietary scanning calculator
|
|
Placebo Comparator: Controlled group
Standard education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The declination of glomerular infiltration rate
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ramathibodi Hospital
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population
-
The Royal Wolverhampton Hospitals NHS TrustCompletedEnd Stage Renal Disease (ESRD) | Chronic Kidney Disease (CKD) | Acute Kidney Injury (AKI) | Estimated Glomerular Filtration Rate (eGFR) | Neutrophil Gelatinase-associated Lipocalin (NGAL) | Serum Creatinine (SCr) | Urine Creatinine (UCr) | Urine Albumin (UAlb)United Kingdom
-
Konya Numune HospitalCompletedChronic Kidney Disease | Glomerular Filtration Rate | Drug ResistanceTurkey
-
Soutien aux Actions contre les Maladies du Globule...NovartisCompletedChange in Albumin to Creatinine Ratio and Glomerular Filtration Rate | Progression of Kidney Failure and or All-cause MortalityFrance
-
Assiut UniversityUnknownStudy of the NAFLD in CKD Patients Using Fibroscan Study
-
Assiut UniversityUnknownEvaluation of Early Inflammatory Process in CKD
-
University of Sao PauloUnknownChronic Kidney Diseases | Chronic Disease | Chronic Diseases in Adolescence | Chronic Disease of Immune SystemBrazil
-
Klinikum Wels-GrieskirchenGenzyme, a Sanofi CompanyCompletedFocus of Study: Prevalence of Fabry Disease in CKD PopulationAustria
-
National Taiwan University HospitalUnknownTo Determine the Prevalence of Latent Tuberculosis in Each Group | To Monitor the Occurrence of Active TuberculosisTaiwan
-
Tulane UniversityNational Kidney FoundationCompletedDepression | Quality of Life | Pain | Generalized Anxiety Disorder | End Stage Renal Disease | Anxiety | Blood Pressure | Major Depressive Disorder | Compliance, Patient | Compliance, Medication | Mood | Heart Rate Fast | Energy Supply; DeficiencyUnited States
-
Novo Nordisk A/SCompletedChronic Kidney Disease | Turner Syndrome | Chronic Renal Insufficiency | Growth Hormone Disorder | Growth Hormone Deficiency in Children | Genetic Disorder | Delivery Systems | Foetal Growth Problem | Small for Gestational AgeFrance
Clinical Trials on Dietary Scanning Calculator
-
prof. dr. Frans B. PlötzDutch Society of Pediatrics; Zorgevaluatie Nederland; Care4Neo; everywhereIMRecruitingEOS | Early-Onset Sepsis, NeonatalNetherlands
-
Mednax Center for Research, Education, Quality...Banner University Medical CenterCompletedMaternal; Chorioamnionitis, Affecting Fetus | Early-Onset Sepses, NeonatalUnited States
-
University of UtahCompletedDecision Support Systems, Clinical | Algorithms | Diarrhea Infectious | Clinical Decision-MakingBangladesh, Mali
-
Duke UniversityWithdrawn
-
Lyda OsorioCOMFANDI CAJA DE COMPENSACION DEL VALLE DEL CAUCA; SISTEMA GENERAL DE REGALIAS... and other collaboratorsCompleted
-
The Cleveland ClinicCompletedVenous ThromboembolismUnited States
-
Medstar Health Research InstituteCompletedPelvic Organ Prolapse | Stress Urinary Incontinence | SatisfactionUnited States
-
Steno Diabetes Center CopenhagenUniversity of CopenhagenCompletedGlucose Metabolism Disorders | Type1diabetes | Type1 Diabetes MellitusDenmark
-
Nepal Mediciti HospitalCompleted