Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 4:11 PM
Study NCT ID:
NCT03383861
Status:
TERMINATED
Last Update Posted:
2024-01-10
First Post:
2017-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition Status, BMD, and SSRIs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13027}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'This is not a clinical trial and is only a retrospective chart review. This was inadvertently entered into the system as a clinical trial.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2017-12-19', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMD t-score', 'timeFrame': 'NHANES DXA measurement taken 2005-2014'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['BMD']}, 'descriptionModule': {'briefSummary': 'The association between selective serotonin reuptake inhibitor (SSRI) use and bone mass density (BMD) has been debated. Some have suggested features of depression, which SSRIs are prescribed to treat, may be a cause of decreased BMD, such as poor overall food intake at the time of SSRI use. Our study seeks to determine whether SSRI use in adults is associated with lower than average BMD, and if there is an association between low micronutrient intake, SSRI use, and a low BMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'NHANES participants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Included adult NHANES participants are those who participated in the Dual-Energy X-ray Absorptiometry (DXA) femur-neck BMD test and responded in full to the demographic, pharmaceutical, and dietary surveys.\n\nExclusion Criteria:\n\n* Pregnancy, incomplete survey responses, incomplete DXA results'}, 'identificationModule': {'nctId': 'NCT03383861', 'briefTitle': 'Nutrition Status, BMD, and SSRIs', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Nutrition Status, Bone Mass Density, and Selective Serotonin Reuptake Inhibitors', 'orgStudyIdInfo': {'id': '174318'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SSRI long-term user', 'description': 'Adults, 655 with an SSRI prescription ≥180 days and identified in the National Health and Nutrition Examination Survey (NHANES) data.', 'interventionNames': ['Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)']}, {'label': 'Non-user', 'description': 'Adults, 12,372 non-users, were identified in the National Health and Nutrition Examination Survey (NHANES) data.', 'interventionNames': ['Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)']}], 'interventions': [{'name': 'Dual-Energy X-ray Absorptiometry (DXA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'BMD t-score derived from DXA scan', 'armGroupLabels': ['Non-user', 'SSRI long-term user']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}