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

NCT ID: NCT02519894

Last Updated: 2015-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-08-31

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

Conditions

Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention group

Intensive low sodium education and immediate sodium intake feedback by dietary scanning calculator

Group Type: EXPERIMENTAL

Dietary Scanning Calculator

Intervention Type: BEHAVIORAL

Controlled group

Standard education

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Dietary Scanning Calculator

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PANTHITA SORNHIRAN

OTHER

Sponsor Role: lead

Responsible Party

PANTHITA SORNHIRAN

PANTHITA SORNHIRAN

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

Ramathibodi Hospital

Identifier Type: -

Identifier Source: org_study_id