Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease

Conditions
-----------------
Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population

Intervention / Treatment
-----------------
* Behavioral: Dietary Scanning Calculator


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intensive low sodium education and immediate sodium intake feedback by dietary scanning calculator | Behavioral: Dietary Scanning Calculator<br> <br> |
| Placebo Comparator: Controlled group<br>Standard education | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The declination of glomerular infiltration rate |  | one year |