Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-03 @ 10:06 AM
Study NCT ID:
NCT02228902
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2014-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Absorption Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C031621', 'term': 'ferrous fumarate'}, {'id': 'C011819', 'term': 'ferrous gluconate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2015-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2014-08-13', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Iron values in the blood', 'timeFrame': '1 month after surgery', 'description': 'Iron levels in teh blood will be measured before and 1,2,3,4,5 and 6 hours after the administration of oral iron replacement in micrograms / dl. This will take place before surgery and one month after surgery. The primary outcome is de difference between iron values pre- and postoperatively.'}], 'secondaryOutcomes': [{'measure': 'difference in absorption between ferrous fumarate and ferrous gluconate', 'timeFrame': '1 month after surgery'}]}, 'conditionsModule': {'conditions': ['Iron Absorption', 'Bariatric Surgery', 'Roux- en -y Gastric Bypass']}, 'referencesModule': {'references': [{'pmid': '29327182', 'type': 'DERIVED', 'citation': 'Schijns W, Ligthart MAP, Berends FJ, Janssen IMC, van Laarhoven CJHM, Aarts EO, de Boer H. Changes in Iron Absorption After Roux-en-Y Gastric Bypass. Obes Surg. 2018 Jun;28(6):1738-1744. doi: 10.1007/s11695-017-3088-5.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: There are indications that the absorption of oral iron supplementation is reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to a insufficient treatment of oral iron suppletion.\n\nMethods: an iron absorption test will be performed pre- and postoperatively in 24 patients. Two groups will be created.\n\nPreoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2 receives a daily dose Losferron (1390mg).\n\nBefore intake of the medicines, a fasting blood sample is taken (baseline), serum iron including ferritin, transferrin and transferrin saturation will be measured. After intake of losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron absorption. All patients undergo a Roux- en -Y gastric bypass.\n\nPostoperatively; one month postoperatively the same absorption test will be repeated in the same patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who are eligible for a primary Roux- en -Y gastric bypass and who have no pre-existing iron deficiency (serum ferritin between 20-200 micrograms/L)\n\nExclusion Criteria:\n\n* blood transfusion one month before ans in the study period. The use of iron containing nutritional supplements, except our standardized multivitamin supplements. Decreased function of the kidney with a GFR of \\< 30ml/min and a serum creatinin below 50 micromol/L. Hb\\< 7.4 mmol/L in females en Hb\\< 8.4 mmol/L in males. Accumulation of iron. Hypersensitivity for ons of the medicinal products. Psychiatric illness. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02228902', 'briefTitle': 'Iron Absorption Trial', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'orgStudyIdInfo': {'id': 'Ironabsorption'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ferrous fumarate', 'description': '12 patients receive ferrous fumarate, 12 patients receive ferrous gluconate', 'interventionNames': ['Drug: Ferrous fumarate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ferrous gluconate', 'description': '12 patients receive ferrous fumarate and 12 patients receive ferrous gluconate', 'interventionNames': ['Drug: Ferrous gluconate']}], 'interventions': [{'name': 'Ferrous fumarate', 'type': 'DRUG', 'description': 'one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate', 'armGroupLabels': ['ferrous fumarate']}, {'name': 'Ferrous gluconate', 'type': 'DRUG', 'otherNames': ['Losferron'], 'description': 'One group receives ferrous fumarate and one group receives ferrous fumarate.', 'armGroupLabels': ['ferrous gluconate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6800WC', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}