Effect of Intensive Low Sodium Restriction on Glomerular... | NCT02519894

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

NCT02519894

Sponsor

PANTHITA SORNHIRAN

Status

Unknown status

Last Update Posted

Aug 11, 2015Estimated

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population

Interventions

Dietary Scanning Calculator

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Aug 2016Estimated

Completion Date

Aug 2016Estimated

First Submitted Date

Aug 9, 2015

First Submission Date that Met QC Criteria

Aug 9, 2015

First Posted Date

Aug 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2015

Last Update Posted Date

Aug 11, 2015Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	Intensive low sodium education and immediate sodium intake feedback by dietary scanning calculator	Behavioral: Dietary Scanning Calculator
Controlled group	Placebo Comparator	Standard education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary Scanning Calculator	Behavioral		Intervention group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided