Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-01-01 @ 1:56 AM
Study NCT ID:
NCT04545528
Status:
WITHDRAWN
Last Update Posted:
2022-10-14
First Post:
2020-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Nutritional Service in the Stone Clinic on the Patient Urine Collection Results
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'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': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'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0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Logistical problems in clinic', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24h Urine collection results', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'to follow changes in the 24 hour urine collection results that are routinely taken as part as follow up: volume in millilitres; calcium, oxalate, magnesium, phosphorus sodium and potassium in mg/day;'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'weight in kilograms'}, {'measure': 'Height', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Height in meters'}, {'measure': 'BMI', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Calculated BMI using the above weight and height'}, {'measure': 'Creatinin in mg/dl', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Lab results'}, {'measure': 'Calcium in mg/dl', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Lab results'}, {'measure': 'sodium in mg/dl', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Lab results'}, {'measure': 'potassium in mg/dl', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Lab results'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['kidney stone', 'kidney Caliculi'], 'conditions': ['Kidney Stone', 'Kidney Calculi']}, 'descriptionModule': {'briefSummary': 'Kidney stone disease has become a common phenomenon in the US and Europe with a growing incidence of about 10%. Life style and dietary changes have a cardinal part in kidney stone prevention. Therefore it was only natural to determine the impact of the addition of a nutritionist to a stone clinic run by a urologist and a nephrologist.', 'detailedDescription': 'Kidney stone disease has become a common phenomenon in the US and Europe with a growing incidence of about 10%. A history of kidney stone disease has also been connected to cardiovascular and renal insufficiency events to a point that kidney stones is looked at today as a systemic predictor of hypertension, cardiovascular disease and more.\n\nSeeing the importance of these risk factors we initiated a stone clinic for our kidney stone patients several years ago run jointly by a urologist and a nephrologist. Seeing that life style and dietary changes have a cardinal part in kidney stone prevention, it was only natural to determine the impact of the addition of a nutritionist to a stone clinic run by a urologist and a nephrologist on our patient parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients18 yo and older referred to out kidney stone clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 yo and older\n* 2 kidneys\n* Kidney or ureteric stone treated surgically or conservatively\n\nExclusion Criteria:\n\n* Single kidney\n* Aberrant kidney anatomy'}, 'identificationModule': {'nctId': 'NCT04545528', 'acronym': 'NUT1', 'briefTitle': 'The Impact of Nutritional Service in the Stone Clinic on the Patient Urine Collection Results', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'The Impact of Nutritional Service in the Stone Clinic on the Patient Urine', 'orgStudyIdInfo': {'id': 'CMC-20-0013-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Test group', 'description': '100 Patients that were referred to our stone clinic for follow up with risk factors for stone recurrence like metabolic syndrome and diabetes, uric acid stones etc. In addition to seeing our urologist and nephrologist these patients will also be referred to a nutritionist in order to balance risk factors and will be followed for one year with our usual blood tests and imaging', 'interventionNames': ['Behavioral: Dietary recommendations']}, {'label': 'Control group', 'description': '100 Patients that were referred to our stone clinic for follow up without risk factors for stone recurrence will see our urologist and nephrologist and will be followed for one year with our usual blood tests and imaging'}], 'interventions': [{'name': 'Dietary recommendations', 'type': 'BEHAVIORAL', 'description': 'The test group will be seen by a nutritionist and will receive specific dietary recommendations according to their specific comorbidities and drugs', 'armGroupLabels': ['Test group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Lady Davis Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ilan Beniamin Klein', 'investigatorAffiliation': 'Carmel Medical Center'}}}}