Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-29 @ 7:18 AM
Study NCT ID:
NCT06869603
Status:
RECRUITING
Last Update Posted:
2025-03-11
First Post:
2024-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Adherence to the Mediterranean Diet in Patients with Recurrent Renal Stones and Disease Osteometabolic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'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': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient eating habits', 'timeFrame': '1-36 months', 'description': 'Questionaries to detect the patients eating habits.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Stones', 'Osteometabolic Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this research protocol is to evaluate the adherence to the Mediterranean diet in patients suffering from recurrent kidney stones and osteometabolic diseases. Results of the study will allow to assess the dietary habits of patients with the above diseases. Given the universal prevalence of nephrolithiasis and osteometabolic diseases, the knowledge of these data appears crucial for the proper management of the dietary approach to prophylaxis secondar'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with idiopathic relapsing nephrolithiasis with evidence instrumental of bilateral renal stones or emission of more than one stone in the past 5 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with idiopathic relapsing nephrolithiasis with evidence instrumental of bilateral renal stones or emission of more than one stone in the past 5 years\n\nExclusion Criteria:\n\n* Patients who had albumin-corrected plasma calcium levels \\> 11.0 mg/dl at the time of the first determination of serum levels of 25 OH vitamin D;\n* Patients who had glomerular filtration rate \\< 60 mL/min/1.73 m2;\n* Patients who had positive personal history of chronic granulomatous disease;\n* pregnancy patients;\n* Positive personal history for morphological abnormalities of the excretory system;\n* incomplete data collection.'}, 'identificationModule': {'nctId': 'NCT06869603', 'briefTitle': 'Evaluation of Adherence to the Mediterranean Diet in Patients with Recurrent Renal Stones and Disease Osteometabolic', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS SYNLAB SDN'}, 'officialTitle': 'Evaluation of Adherence to the Mediterranean Diet in Patients with Recurrent Renal Stones and Disease Osteometabolic', 'orgStudyIdInfo': {'id': '3/23'}}, 'contactsLocationsModule': {'locations': [{'zip': '80143', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Monica Franzese, PhD', 'role': 'CONTACT', 'email': 'direzionescientifica.irccssdn@synlab.it', 'phone': '+393334041413'}], 'facility': 'Irccs Synlab Sdn', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS SYNLAB SDN', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Clinical Medicine and Surgery - University of Naples Federico II', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}