Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-31 @ 3:55 PM
Study NCT ID:
NCT01590134
Status:
UNKNOWN
Last Update Posted:
2015-02-04
First Post:
2012-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Iron Supplementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-27', 'releaseDate': '2023-09-25'}, {'resetDate': '2024-08-21', 'releaseDate': '2024-04-03'}], 'estimatedResultsFirstSubmitDate': '2023-09-25'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C020748', 'term': 'ferrous sulfate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-03', 'studyFirstSubmitDate': '2012-04-30', 'studyFirstSubmitQcDate': '2012-05-01', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Iron levels in blood tests', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['volunteers', 'Pilot study', 'There are no pre registration evaluations.', 'Inclusion criteria: to be a healthy, consenting volunteer not currently receiving iron supplements.', 'Exclusion criteria: 1) Needle phobia; 2) Currently receiving iron supplements; 3) Unable to provide informed consent'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Further analyses are in progress for full manuscript.'}, {'type': 'RESULT', 'citation': 'Gilson C, Busbridge M, Shovlin CL, Iron tablet profiling. Hematology Reports 2013: 5 (s1),30-1'}]}, 'descriptionModule': {'briefSummary': 'Each year, 5 million packs of iron tablets are dispensed in England and Wales to treat anaemia due to iron deficiency. Iron tablets are not always easy to take. The investigators think that there could be ways to reduce the number of iron tablets needed, by increasing the dietary intake of iron. In this study the investigators will assess the efficacy and safety of a dietary iron supplement compared to iron tablets using controls and new biomarkers.', 'detailedDescription': '18 healthy individuals will be randomised to one of three arms, and for two consecutive mornings, will receive either an iron tablet (ferrous sulphate 200mg), a dietary iron supplement, or no agent.\n\nBlood and urine samples will be collected pre-dose, and at stated intervals 2.5, 4, 7, 24 and 48 hours post first dose.\n\nThe standard deviations of data obtained in this pilot study will be used to perform power calculations for our future studies in this field.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be a healthy, consenting volunteer not currently receiving iron supplements.\n\nExclusion Criteria:\n\n1. Needle phobia\n2. Currently receiving iron supplements\n3. Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01590134', 'briefTitle': 'The Efficacy and Safety of Iron Supplementation', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Pilot Studies on the Efficacy and Safety of Dietary Iron Supplementation', 'orgStudyIdInfo': {'id': 'CLS/2012/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Following randomisation,to no active intervention, blood and urine samples will be collected at 6 stated intervals over a 48 hour period\n\nTotal number of participants in arm = 6'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iron control', 'description': 'Following randomisation, on each of two consecutive mornings, the participant will receive a single dose of ferrous sulphate 200mg. Blood and urine samples will be collected pre first dose, and at 5 further stated intervals over a 48 hour period.\n\nTotal number of participants in arm = 6', 'interventionNames': ['Drug: Ferrous sulphate']}, {'type': 'EXPERIMENTAL', 'label': 'Dietary supplement', 'description': 'Following randomisation, on each of two consecutive mornings, the participant will receive the experimental dietary iron supplement. Blood and urine samples will be collected pre first dose, and at 5 further stated intervals over a 48 hour period.\n\nToal participants in arm = 6', 'interventionNames': ['Dietary Supplement: Dietary supplement of iron']}], 'interventions': [{'name': 'Dietary supplement of iron', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron', 'armGroupLabels': ['Dietary supplement']}, {'name': 'Ferrous sulphate', 'type': 'DRUG', 'description': '200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary', 'armGroupLabels': ['Iron control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W12 0NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Wellcome Trust-McMichael Clinical Research Facility, Imperial college London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Claire L Shovlin, PhD MA MB BChir FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-09-25', 'type': 'RELEASE'}, {'date': '2024-03-27', 'type': 'RESET'}, {'date': '2024-04-03', 'type': 'RELEASE'}, {'date': '2024-08-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Imperial College London'}}}}