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

PANTHITA SORNHIRAN

Status

Unknown

Conditions

Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population

Treatments

Behavioral: Dietary Scanning Calculator

Study type

Interventional

Funder types

Other

Identifiers

NCT02519894

Ramathibodi Hospital

Details and patient eligibility

About

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

Enrollment

600 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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