Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-06 @ 3:35 PM
Study NCT ID:
NCT03397550
Status:
WITHDRAWN
Last Update Posted:
2022-10-12
First Post:
2017-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Salt Restriction and Taste Sensitivity in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'feasibility is being questioned', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-06-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-08', 'studyFirstSubmitDate': '2017-12-13', 'studyFirstSubmitQcDate': '2018-01-10', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ratings of taste sensitivity assessed by the ISO method of investigating sensitivity of taste（ISO 3972:1991）', 'timeFrame': 'up to 12 weeks after intervention', 'description': 'Taste sensitivity is measured by five taste solutions（salty、sour、bitter、sweet、umami). Every taste solution contains 8 different concentration. Detection , recognition and difference thresholds will be measured .Their definitions are as bellow.\n\nDetection threshold：minimum value of sensory stimulus needed to give rise to a sensation. The sensation need not be identified.\n\nRecognition threshold：minimum value of a sensory stimulus permitting identification of the sensation perceived.\n\nDifference threshold：value of the smallest perceptible difference in the physical intensity of a stimulus.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['taste threshold', 'salt restriction'], 'conditions': ['Renal Insufficiency, Chronic', 'Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '23046735', 'type': 'RESULT', 'citation': 'Lynch KE, Lynch R, Curhan GC, Brunelli SM. Altered taste perception and nutritional status among hemodialysis patients. J Ren Nutr. 2013 Jul;23(4):288-295.e1. doi: 10.1053/j.jrn.2012.08.009. Epub 2012 Oct 6.'}, {'pmid': '19516246', 'type': 'RESULT', 'citation': 'Kusaba T, Mori Y, Masami O, Hiroko N, Adachi T, Sugishita C, Sonomura K, Kimura T, Kishimoto N, Nakagawa H, Okigaki M, Hatta T, Matsubara H. Sodium restriction improves the gustatory threshold for salty taste in patients with chronic kidney disease. Kidney Int. 2009 Sep;76(6):638-43. doi: 10.1038/ki.2009.214. Epub 2009 Jun 10.'}, {'pmid': '9915887', 'type': 'RESULT', 'citation': 'Middleton RA, Allman-Farinelli MA. Taste sensitivity is altered in patients with chronic renal failure receiving continuous ambulatory peritoneal dialysis. J Nutr. 1999 Jan;129(1):122-5. doi: 10.1093/jn/129.1.122.'}, {'pmid': '25192896', 'type': 'RESULT', 'citation': 'McMahon EJ, Campbell KL, Bauer JD. Taste perception in kidney disease and relationship to dietary sodium intake. Appetite. 2014 Dec;83:236-241. doi: 10.1016/j.appet.2014.08.036. Epub 2014 Sep 2.'}]}, 'descriptionModule': {'briefSummary': 'The compliance of salt restriction in patients with CKD may be associated with taste sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'stage 3-5 CKD patients', 'eligibilityCriteria': "Inclusion Criteria:\n\n* stage 3-5 CKD patients\n* clinical stable\n\nExclusion Criteria:\n\n* renal replacement therapy\n* cancer\n* systemic infection\n* Alzheimer's disease\n* acute cardiovascular events, active hepatitis\n* all other study-obstructive conditions"}, 'identificationModule': {'nctId': 'NCT03397550', 'briefTitle': 'The Relationship Between Salt Restriction and Taste Sensitivity in Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'The Relationship Between Salt Restriction and Taste Sensitivity in Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'pekingUFH-cn'}}, 'armsInterventionsModule': {'interventions': [{'name': 'salt restriction education', 'type': 'OTHER', 'description': 'Salt intake target：\\<5g/d Method：the standard salt restriction education will be lasting for 10-15 minutes by oral explanation at baseline.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jie Dong', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking Universiy First Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nephrology chief physician', 'investigatorFullName': 'Dong Jie', 'investigatorAffiliation': 'Peking University First Hospital'}}}}