Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-02 @ 1:56 PM
Study NCT ID:
NCT03825393
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2019-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome
Sponsor:
Organization:
Raw JSON
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PSQI measures subjective sleep quality, duration and latency of sleep, sleep disorders, habitual sleep efficiency, daytime dysfunction and use of medication for sleeping. PSQI distinguishes "poor" sleep from "good" sleep.\n\nminimum score 1 maximum score 9\n\n≥5 total points in PSQI mean "poor" sleep. \\<5 total points in PSQI mean good sleep.', 'unitOfMeasure': 'score on a questionnarie', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '100 This index applied only Firomyalgia syndrome group'}, {'type': 'PRIMARY', 'title': 'Ferritin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control Group'}, {'id': 'OG001', 'title': 'Fibromyalgia', 'description': 'Fibromyalgia syndrome'}], 'classes': [{'categories': [{'measurements': [{'value': '34.91', 'groupId': 'OG000', 'lowerLimit': '17.87', 'upperLimit': '55.12'}, {'value': '20.95', 'groupId': 'OG001', 'lowerLimit': '11.75', 'upperLimit': '39.55'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 year', 'description': 'Iron deficiency marker', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '200'}, {'type': 'SECONDARY', 'title': 'Fibromyalgia Impact Questionnarie Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibromiyalgia', 'description': '100 Fibromyalgia Patient Group 100 Control Group'}], 'classes': [{'categories': [{'measurements': [{'value': '61.69', 'spread': '17.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Fibromyalgia Impact Questionnaire (FIQ) is a 10-item evaluation tool developed to measure status, prognosis and outcomes of FMS patients. Total points vary from 0 to 100. Higher points show the effect of FMS on functionality.\n\nmimimum score 0 maximum score 100 higher scores shows poor functionality.', 'unitOfMeasure': 'score on a questionnarie', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '100 This questionnarie applied only Firomyalgia syndrome group'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibromiyalgia', 'description': '100 Fibromyalgia Patient Group 100 Control Group'}], 'classes': [{'categories': [{'measurements': [{'value': '15.73', 'spread': '9.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Beck Depression Inventory (BDI) is a 21-item questionnaire evaluating the presence and severity of depression. Higher points mean heavier depression (0-9 points: minimum depression; 10-18 points: slight depression; 19-29 points: moderate depression; 30-63 points: severe depression).\n\nminimum 0 maximum 63 points higher scores mean worse outcome.', 'unitOfMeasure': 'score on a questionnarie', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '100 This questionnarie applied only Firomyalgia syndrome group'}, {'type': 'SECONDARY', 'title': 'Beck Anxiety Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibromiyalgia', 'description': '100 Fibromyalgia Patient Group 100 Control Group'}], 'classes': [{'categories': [{'measurements': [{'value': '22.58', 'spread': '11.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': "Beck Anxiety Inventory is a short, easily applied and graded, 21-item questionnaire to evaluate the severity of patients' anxiety. Total points vary from 0 to 63 (0-9 points: normal; 10-18 points: slight to moderate anxiety; 19-29 points: moderate to severe anxiety and 30-63 points: very severe anxiety).\n\nminimum 0 maximum 63 points higher scores mean worse outcome", 'unitOfMeasure': 'score on a questionnarie', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '100 This inventory applied only Firomyalgia syndrome group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fibromiyalgia', 'description': '100 Fibromyalgia Patient Group'}, {'id': 'FG001', 'title': 'Control', 'description': '100 Control Group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fibromiyalgia', 'description': '100 Fibromyalgia Patient Group'}, {'id': 'BG001', 'title': 'Control', 'description': '100 Control Group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ferritin level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20.95', 'groupId': 'BG000', 'lowerLimit': '11.75', 'upperLimit': '39.55'}, {'value': '34.91', 'groupId': 'BG001', 'lowerLimit': '17.87', 'upperLimit': '55.12'}, {'value': '32.92', 'groupId': 'BG002', 'lowerLimit': '14.65', 'upperLimit': '47.35'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-01', 'size': 134748, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-04T04:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2019-01-26', 'resultsFirstSubmitDate': '2019-05-26', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-04', 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pitsburgh Sleep Quality Index', 'timeFrame': '1 year', 'description': 'Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire measuring sleep quality and disorders in a time period of one month. PSQI measures subjective sleep quality, duration and latency of sleep, sleep disorders, habitual sleep efficiency, daytime dysfunction and use of medication for sleeping. PSQI distinguishes "poor" sleep from "good" sleep.\n\nminimum score 1 maximum score 9\n\n≥5 total points in PSQI mean "poor" sleep. \\<5 total points in PSQI mean good sleep.'}, {'measure': 'Ferritin Level', 'timeFrame': '1 year', 'description': 'Iron deficiency marker'}], 'secondaryOutcomes': [{'measure': 'Fibromyalgia Impact Questionnarie Scores', 'timeFrame': '1 year', 'description': 'Fibromyalgia Impact Questionnaire (FIQ) is a 10-item evaluation tool developed to measure status, prognosis and outcomes of FMS patients. Total points vary from 0 to 100. Higher points show the effect of FMS on functionality.\n\nmimimum score 0 maximum score 100 higher scores shows poor functionality.'}, {'measure': 'Beck Depression Inventory', 'timeFrame': '1 year', 'description': 'Beck Depression Inventory (BDI) is a 21-item questionnaire evaluating the presence and severity of depression. Higher points mean heavier depression (0-9 points: minimum depression; 10-18 points: slight depression; 19-29 points: moderate depression; 30-63 points: severe depression).\n\nminimum 0 maximum 63 points higher scores mean worse outcome.'}, {'measure': 'Beck Anxiety Inventory', 'timeFrame': '1 year', 'description': "Beck Anxiety Inventory is a short, easily applied and graded, 21-item questionnaire to evaluate the severity of patients' anxiety. Total points vary from 0 to 63 (0-9 points: normal; 10-18 points: slight to moderate anxiety; 19-29 points: moderate to severe anxiety and 30-63 points: very severe anxiety).\n\nminimum 0 maximum 63 points higher scores mean worse outcome"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia Syndrome, Ferritin, Sleep'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to evaluate the association between ferritin levels and clinical parameters in patients with fibromyalgia syndrome.', 'detailedDescription': 'This sectional study included 100 patients with non-anemic FMS diagnosis and 100 patients with non anemic non FMS diagnosis whose ferritin levels were measured within the last four weeks. The participants were evaluated using Fibromyalgia Impact Questionnaire (FIQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Pittsburg Sleep Quality Index (PSQI) as well as with a questionnaire form about descriptive characteristics. Serum ferritin level of \\<30 ng/mL was considered iron deficiency.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This sectional study included 100 female patients older than 18 years of age who presented to Physical Treatment and Rehabilitation polyclinic in 2016-17 period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fibromyalgi syndrome patients\n* ferritin levels were measured within the last four weeks\n\nExclusion Criteria:\n\n* parenteral or enteral iron usage in last four weeks\n* hemoglobin level was less than 12 g/dl\n* infection\n* malignity\n* active inflammatory arthritis\n* serious skin variations\n* serious peripheral vascular disease\n* iron storing disorder\n* pregnant or lactating patients'}, 'identificationModule': {'nctId': 'NCT03825393', 'briefTitle': 'Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tokat State Hospital'}, 'officialTitle': 'Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome', 'orgStudyIdInfo': {'id': '123456'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fibromyalgia', 'description': 'Non-anemic FMS patients who were diagnosed based on 2011 FMS diagnostic criteria of the American Rheumatology College'}, {'label': 'Control', 'description': 'Non-anemic women without a FMS diagnosis'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'sevil okan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Doctor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokat State Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Sevil Okan', 'investigatorAffiliation': 'Tokat State Hospital'}}}}