Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
Primary Purpose
Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dietary Scanning Calculator
Sponsored by
About this trial
This is an interventional health services research trial for Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Controlled group
Arm Description
Intensive low sodium education and immediate sodium intake feedback by dietary scanning calculator
Standard education
Outcomes
Primary Outcome Measures
The declination of glomerular infiltration rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02519894
Brief Title
Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
Official Title
Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
PANTHITA SORNHIRAN
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intensive low sodium education and immediate sodium intake feedback by dietary scanning calculator
Arm Title
Controlled group
Arm Type
Placebo Comparator
Arm Description
Standard education
Intervention Type
Behavioral
Intervention Name(s)
Dietary Scanning Calculator
Primary Outcome Measure Information:
Title
The declination of glomerular infiltration rate
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
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