Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-26 @ 12:21 AM
Study NCT ID:
NCT01555060
Status:
COMPLETED
Last Update Posted:
2014-01-23
First Post:
2012-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemoglobin and Iron Recovery Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C011819', 'term': 'ferrous gluconate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-22', 'studyFirstSubmitDate': '2012-03-09', 'studyFirstSubmitQcDate': '2012-03-13', 'lastUpdatePostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to recovery of hemoglobin after blood donation', 'timeFrame': 'Up to 24 weeks after blood donation', 'description': 'Hemoglobin will be measured 3-7 days and 2, 4, 8, 12, 16 and 24 weeks after blood donation. A nonlinear regression of hemoglobin vs time since donation will be used to determine time to recovery of hemoglobin to 80% of the pre-donation level.'}], 'secondaryOutcomes': [{'measure': 'Iron stores', 'timeFrame': 'Up to 24 weeks after blood donation', 'description': 'Ferritin will be measured 3-7 days and 2, 4, 8, 12, 16 and 24 weeks after blood donation. A nonlinear regression of hemoglobin vs time since donation will be used to determine time to recovery of to pre-donation iron stores.'}, {'measure': 'Total body iron', 'timeFrame': '24 weeks after blood donation', 'description': 'Soluble transferrin receptor (sTfR) in blood will be measured 3-7 days and 24 weeks after blood donation. The ratio of sTfR to ferritin will provide a measure of total body iron at the two time points. Recovery of total body iron will be estimated from the difference between the ratios at the two time points.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hemoglobin recovery', 'iron recovery', 'iron supplements'], 'conditions': ['Recovery of Hemoglobin and Iron Stores After Blood Donation']}, 'referencesModule': {'references': [{'pmid': '32243609', 'type': 'DERIVED', 'citation': 'Mast AE, Szabo A, Stone M, Cable RG, Spencer BR, Kiss JE; NHLBI Recipient Epidemiology Donor Evaluation Study (REDS)-III. The benefits of iron supplementation following blood donation vary with baseline iron status. Am J Hematol. 2020 Jul;95(7):784-791. doi: 10.1002/ajh.25800. Epub 2020 Apr 15.'}, {'pmid': '27232535', 'type': 'DERIVED', 'citation': 'Cable RG, Brambilla D, Glynn SA, Kleinman S, Mast AE, Spencer BR, Stone M, Kiss JE; National Heart, Lung, and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Effect of iron supplementation on iron stores and total body iron after whole blood donation. Transfusion. 2016 Aug;56(8):2005-12. doi: 10.1111/trf.13659. Epub 2016 May 27.'}, {'pmid': '25668261', 'type': 'DERIVED', 'citation': 'Kiss JE, Brambilla D, Glynn SA, Mast AE, Spencer BR, Stone M, Kleinman SH, Cable RG; National Heart, Lung, and Blood Institute (NHLBI) Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Oral iron supplementation after blood donation: a randomized clinical trial. JAMA. 2015 Feb 10;313(6):575-83. doi: 10.1001/jama.2015.119.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of daily iron supplements after blood donation on time to recovery of hemoglobin and iron stores. The study will also determine whether the effect of iron supplements on time to recovery is different in men and women, in older vs. younger donors (\\<60 years old vs. at least 60 years old) and in donors with replete vs. diminished pre-donation iron stores.', 'detailedDescription': 'The effect of taking iron supplements after blood donation on time to recovery of hemoglobin has been documented but it is not clear whether the benefits of iron supplements vary with age, gender or iron stores. To study this issue, individuals who are eligible to donate blood, based on hemoglobin level, will be randomized to receive daily iron supplements or no supplements. Randomization will be stratified on gender (male or female), age (\\<60 years old vs. at least 60 years old) and iron status (serum ferritin \\>26 vs serum ferritin no greater than 26). Subjects will be followed for 24 weeks with periodic blood draws to determine time to recovery of hemoglobin and iron stores. A 7 ml (about 1.5 teaspoons) blood sample will be drawn at each of seven study visits over the 24 weeks to track recovery of hemoglobin and iron.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* potential blood donors with hemoglobin of at least 12.5 gm/dL\n* no blood donation for at least 4 months\n* successful donation of a unit of whole blood\n\nExclusion Criteria:\n\n* individuals who are taking iron supplements including multivitamins containing iron and refuse to stop do so for the 24 weeks of the study.\n* baseline ferritin \\>300 ug/L (to exclude individuals with hemochromatosis)'}, 'identificationModule': {'nctId': 'NCT01555060', 'acronym': 'HEIRS', 'briefTitle': 'Hemoglobin and Iron Recovery Study', 'organization': {'class': 'NIH', 'fullName': 'National Heart, Lung, and Blood Institute (NHLBI)'}, 'officialTitle': 'Hemoglobin and Iron Recovery Study', 'orgStudyIdInfo': {'id': '714'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iron supplements', 'description': 'Subjects who are randomized to receive daily iron supplements after donating blood', 'interventionNames': ['Dietary Supplement: ferrous gluconate']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects who are randomized not to receive daily iron supplements after donating blood'}], 'interventions': [{'name': 'ferrous gluconate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'daily capsule of ferrous gluconate containing 38 mg of elemental iron', 'armGroupLabels': ['Iron supplements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Blood Centers of the Pacific', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06032', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'American Red Cross, Connecticut Region', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Institute for Transfusion Medicine', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Blood Center of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Joe Kiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Transfusion Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'collaborators': [{'name': 'Institute for Transfusion Medicine', 'class': 'UNKNOWN'}, {'name': 'Versiti', 'class': 'OTHER'}, {'name': 'Blood Centers of the Pacific', 'class': 'UNKNOWN'}, {'name': 'American National Red Cross', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'Vitalant Research Institute', 'class': 'OTHER'}, {'name': 'RTI International', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}