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

Not Applicable

• Conditions: Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population
• Interventions: Behavioral: Dietary Scanning Calculator

• Registration Number: NCT02519894
• Lead Sponsor: PANTHITA SORNHIRAN

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-08
• Study Start: 2015-08
• Study First Submitted: 2015-08-09
• Study First Submitted QC: 2015-08-09
• Last Update Submitted: 2015-08-09
• Study First Posted: 2015-08-11
• Last Update Posted: 2015-08-11
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Dietary Scanning Calculator	Intensive low sodium education and immediate sodium intake feedback by dietary scanning calculator

Primary Outcome Measures

Name	Time	Method
The declination of glomerular infiltration rate	one year