search
Back to results

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
PANTHITA SORNHIRAN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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

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

    First Posted
    August 9, 2015
    Last Updated
    August 9, 2015
    Sponsor
    PANTHITA SORNHIRAN
    search

    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

    We'll reach out to this number within 24 hrs