Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-05 @ 6:07 PM
Study NCT ID:
NCT02311257
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2014-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survey on Supplement Use in Mitochondrial Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028361', 'term': 'Mitochondrial Diseases'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-21', 'studyFirstSubmitDate': '2014-09-12', 'studyFirstSubmitQcDate': '2014-12-05', 'lastUpdatePostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of nutritional supplement use in patients with mitochondrial disease.', 'timeFrame': 'Up to one year after study activation.', 'description': 'This cross-sectional survey will assess nutritional supplements used by patients with mitochondrial disease.'}], 'secondaryOutcomes': [{'measure': 'Assess the attitudes of patients and parents towards use of nutritional supplements in patients with mitochondrial disease', 'timeFrame': 'Upt to one year after study activation.', 'description': "This cross-sectional survey will assess patients' and parents' attitudes (comfort level and perceptions of efficacy) of use of nutritional supplements in patients with mitochondrial disease."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mitochondrial Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.rarediseasesnetwork.org/namdc/', 'label': 'Rare Diseases Clinical Research Network NAMDC page'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about the use of nutritional supplements in patients with mitochondrial disease.', 'detailedDescription': 'Our goal is to better assess which nutritional supplements are prescribed to patients with mitochondrial disorders, the monitoring obtained and whether any subjective improvements are noted by the patients or their caregivers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited through the NAMDC Clinical Registry and RDCRN Contact Registry. Additional means of recruitment may be used to direct patients to join the NAMDC or RDCRN registries.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NAMDC Clinical Registry or RDCRN Contact Registry participant\n* Diagnosis of a mitochondrial disease confirmed by either electron transport chain abnormalities or molecular testing.\n\nExclusion Criteria:\n\n* Lack of participation in NAMDC or RDCRN registries\n* Diagnosis of mitochondrial disorder not confirmed by ETC studies or molecular diagnosis'}, 'identificationModule': {'nctId': 'NCT02311257', 'briefTitle': 'Survey on Supplement Use in Mitochondrial Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Survey on Supplement Use in Mitochondrial Disease', 'orgStudyIdInfo': {'id': 'NAMDC7411'}}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Sumit Parikh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Amel Karaa, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachussetts General Hospital'}, {'name': 'Michio Hirano, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}