Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT02519894
Status:
UNKNOWN
Last Update Posted:
2015-08-11
First Post:
2015-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-09', 'studyFirstSubmitDate': '2015-08-09', 'studyFirstSubmitQcDate': '2015-08-09', 'lastUpdatePostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The declination of glomerular infiltration rate', 'timeFrame': 'one year'}]}, 'conditionsModule': {'conditions': ['Declination of Glomerular Infiltration Rate in Chronic Kidney Disease Population']}, 'descriptionModule': {'briefSummary': 'Introduction :\n\nDue 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.\n\nThe study hypothesis :\n\nIntense 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\n\nObjectives :\n\nTo 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.\n\nStudy design :\n\nMulticenter, open labeled, parallel, randomized controlled trial\n\nSample size : 600\n\nPrimary outcome : GFR reduction (CKD-EPI)\n\nSecondary outcome :\n\n* Achievement rate of Na intake \\< 2 g/day (Urine Na \\< 90 mEq/day)\n* Blood pressure difference\n* Proportions of patients with BP reached the target (130/80 mmHg)\n* Number of anti-hypertensive drugs use to achieve BP target\n* Urine albumin/creatinine ratio\n* Major Adverse Cardiac Events (MACE)\n* Cardio-ankle vascular index (CAVI)\n* ankle-brachial index (ABI)\n\nDocumentary Proof of Ethical Clearance :\n\nThis project has been reviewed and approved by the Comittee on Human Rights Related to Research Involving Human Subjects , based on the declaration of Helsinki'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD stage 3-4 (eGFR 15-59 mL/min/1.73m²)\n* Microalbuminuria\n* Any blood pressure level\n\nExclusion Criteria:\n\n* Salt - losing conditions\n* Hyponatremia (Na \\< 135 mg/dL) or Hypernatremia (Na \\> 145 mg/dL)\n* Bilateral renal artery stenosis\n* Severe comorbid disease or life expectancy \\<1 year (severe cardiovascular disease, chronic liver disease, severe infection , malignancy)\n* Immunosuppressant used'}, 'identificationModule': {'nctId': 'NCT02519894', 'briefTitle': 'Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'Ramathibodi Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intensive low sodium education and immediate sodium intake feedback by dietary scanning calculator', 'interventionNames': ['Behavioral: Dietary Scanning Calculator']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Controlled group', 'description': 'Standard education'}], 'interventions': [{'name': 'Dietary Scanning Calculator', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PANTHITA SORNHIRAN', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PANTHITA SORNHIRAN', 'investigatorFullName': 'PANTHITA SORNHIRAN', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}