Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT05738005
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2023-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietary Reporting in the Amyloidoses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000686', 'term': 'Amyloidosis'}], 'ancestors': [{'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000682', 'term': 'Amyloid'}], 'ancestors': [{'id': 'D046912', 'term': 'Multiprotein Complexes'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence Rate', 'timeFrame': '56 days', 'description': "The adherence is defined by the status (yes vs. no) of data recording per day; The adherence rate will be calculated by the ratio of the number of days of adherence to the total number of days of trial (i.e., 56 days); The status of data recording per day will be considered 'yes' if the participant completes a daily survey."}], 'secondaryOutcomes': [{'measure': 'Subsequent adherence rate', 'timeFrame': '63 days (= 56 days + Week 10)', 'description': "The subsequent adherence is the status of data recording per day during the third phase (Week 10) of trial participation (i.e., 7 days); The subsequent adherence rate will be calculated by the ratio of the number of days of adherence during the third phase (Week 10) of trial participation (i.e., 7 days); The status of data recording per day will be considered 'yes' if the participant completes a daily survey."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyloidosis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about malnutrition and weight loss in patients with Amyloidosis.\n\nThe main question it aims to answer is:\n\nIs it feasible to use a low-cost nutrition-based application (apps) for use on a smartphone to obtain detailed information on caloric intake in Amyloidosis patients\n\nParticipants will be asked to:\n\n* Download the MyFitnessPal application on their smartphone and view an online tutorial\n* After a week of practice, from weeks 2-9, participants will enter daily dietary intake as well as daily herbal/alternative supplement intake into the MyFitnessPal application on their smartphone.\n* complete a questionnaire prior to starting the application, after week 2 and at week 10 after starting the application'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosed with any type of amyloidosis\n* Speak, read and write in English\n* Willing to use the MyFitnessPal app on their own smartphone\n\nExclusion Criteria:\n\n* a planned autologous stem cell transplant or a solid organ transplant in the 12 weeks after enrollment\n* cognitive or perceptual disturbances'}, 'identificationModule': {'nctId': 'NCT05738005', 'acronym': 'DRITA', 'briefTitle': 'Dietary Reporting in the Amyloidoses', 'organization': {'class': 'OTHER', 'fullName': 'Barbara Ann Karmanos Cancer Institute'}, 'officialTitle': 'DRITA Pilot Trial: Dietary Reporting in the Amyloidoses', 'orgStudyIdInfo': {'id': '2022-067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)', 'description': 'MyFitnessPal smartphone application is used to track daily dietary intake and herbal/alternative supplements.', 'interventionNames': ['Other: Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)']}], 'interventions': [{'name': 'Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)', 'type': 'OTHER', 'description': "Amyloidosis patients will use MyFitnessPal application to track dietary intake and use of herbal/alternative supplements in from week 2-9. Patient's usage of the application and questionnaires completed by the patient at the start, Week 2 and Week 10 will determine feasibility.", 'armGroupLabels': ['Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Zonder, MD', 'role': 'CONTACT', 'email': 'zonderj@karmanos.org', 'phone': '313-576-8732'}, {'name': 'Andrew Kin, M.D.', 'role': 'CONTACT'}, {'name': 'Navid Mahabadi, D.O.', 'role': 'CONTACT'}, {'name': 'Felicity WK Harper, PhD', 'role': 'CONTACT'}, {'name': 'Jennifer Beebe-Dimmer, PhD', 'role': 'CONTACT'}, {'name': 'Jacob Katzman', 'role': 'CONTACT'}, {'name': 'Abdul Khan, M.D.', 'role': 'CONTACT'}], 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'centralContacts': [{'name': 'Jeffrey Zonder, MD', 'role': 'CONTACT', 'email': 'zonderj@karmanos.org', 'phone': '313-576-8732'}], 'overallOfficials': [{'name': 'Jeffrey Zonder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barbara Ann Karmanos Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barbara Ann Karmanos Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Multiple Myeloma Multidisciplinary team leader, M.D.', 'investigatorFullName': 'Jeffrey Zonder', 'investigatorAffiliation': 'Barbara Ann Karmanos Cancer Institute'}}}}