Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-30 @ 7:26 AM
Study NCT ID:
NCT00881803
Status:
COMPLETED
Last Update Posted:
2012-05-23
First Post:
2009-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron & Vitamin C Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be obtained for analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-21', 'studyFirstSubmitDate': '2009-03-25', 'studyFirstSubmitQcDate': '2009-04-14', 'lastUpdatePostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine iron status if supplemented with ascorbic acid (AA) and/or iron compared to supplementation with iron or AA.', 'timeFrame': '1 episode, at least 6 months after consistent ascorbic acid and/or iron supplementation'}], 'secondaryOutcomes': [{'measure': 'Determine the prevalence of high iron status if receiving supplementation with both iron and AA compared to supplementation with iron or AA.', 'timeFrame': '1 episode, at least 6 months after consistent ascorbic acid and/or iron supplementation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal Cord Injuries', 'Ascorbic Acid', 'Vitamin C', 'Iron', 'Dietary Supplements'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'Iron overload is a life-threatening condition that can lead to liver disease, cardiac disease, diabetes and arthritis. Simultaneous supplementation with both iron and AA may place individuals with SCI at risk for iron overload as well as oxidative damage by iron-generated free radicals. Both conditions of high and low iron stores may present with common signs and symptoms. Accurate diagnosis of iron disorder should consider CRP, hematocrit, hemoglobin, serum iron, TIBC, percent saturation of iron binding capacity, serum ferritin and hepcidin.\n\nThe investigators are proposing a study to determine the effect of concurrent AA and iron supplementation on iron status of individuals with SCI. The investigators goal is to identify abnormal status that may be attributed to simultaneous supplementation of iron and AA to develop future supplementation protocols in this population for optimal iron status.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'US Veterans with spinal cord injuries greater than 6 months who are located near Bronx, NY', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male\n2. 18 years to 90 years of age\n3. Medically stable\n4. Chronic SCI (\\>6 months post injury) without regard to the level or completeness of lesion\n5. Supplementation with:\n\n * A standard recommended dose of 120-200 mg oral elemental iron (tablet or liquid; ferrous sulfate, fumarate or gluconate forms) for a minimum of 6 months; or\n * A standard recommended dose of 250-2,000 mg AA per day for a minimum of 6 months; or\n * Both 120-200 mg oral elemental iron AND 250-2,000 mg AA per day for a minimum of 6 months.\n6. Veteran\n\nExclusion Criteria:\n\nAcute cardiovascular, pulmonary or renal conditions'}, 'identificationModule': {'nctId': 'NCT00881803', 'briefTitle': 'Iron & Vitamin C Study', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Implications of Concurrent Iron and Ascorbic Acid Supplementation on Iron Status in Persons With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'B4162C-6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Ascorbic Acid Supplementation Only'}, {'label': 'Group 2', 'description': 'Iron Supplementation Only'}, {'label': 'Group 3', 'description': 'Concurrent Ascorbic Acid \\& Iron Supplementation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'VA Medical Center, Bronx', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'William Bauman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Medical Center, Bronx'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}