Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-25 @ 12:10 PM
Study NCT ID:
NCT06596161
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iron Therpay and Fatigue in Women of Reprodcutive Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2024-09-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Score improvemnt', 'timeFrame': '60 days', 'description': 'improvement in fatigue levels'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fatigue'], 'conditions': ['Fatigue Syndrome, Chronic', 'Fatigue']}, 'descriptionModule': {'briefSummary': 'For the assessment of anemia and then assessment of fatigue levels in non-anemic women followed by assessment of iron levels and intervention of iron and placebo'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females of reproductive age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nreproductive age non-anemic fatigued\n\nExclusion Criteria:\n\nanemiac males'}, 'identificationModule': {'nctId': 'NCT06596161', 'briefTitle': 'Iron Therpay and Fatigue in Women of Reprodcutive Age', 'organization': {'class': 'OTHER', 'fullName': 'Central Park Medical College'}, 'officialTitle': 'Effect or Iron Therapy on Fatigue Symptoms in Non-anemic Iron Deficient Women of Reproductive Age', 'orgStudyIdInfo': {'id': 'CPMC/IRB-No/1388'}, 'secondaryIdInfos': [{'id': 'CPMC', 'type': 'OTHER', 'domain': 'CPTH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Receiving Iron', 'interventionNames': ['Drug: Iron sucrose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Receiving Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Iron sucrose', 'type': 'DRUG', 'description': 'Receving iron', 'armGroupLabels': ['Study Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Central Park Teaching Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Park Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}