Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 9:33 PM
Study NCT ID:
NCT02517151
Status:
UNKNOWN
Last Update Posted:
2015-09-10
First Post:
2015-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-09', 'studyFirstSubmitDate': '2015-08-04', 'studyFirstSubmitQcDate': '2015-08-05', 'lastUpdatePostDateStruct': {'date': '2015-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'chronic fatigue remission', 'timeFrame': 'Week 24', 'description': 'Multidimensional fatigue inventory (MFI-20) \\<13'}], 'secondaryOutcomes': [{'measure': 'Chronic fatigue reduction', 'timeFrame': 'Week 24', 'description': 'MFI-20 reduction of at least 4 points (absolute MFI-20\\>13)'}, {'measure': 'chronic fatigue remission', 'timeFrame': 'Week 12', 'description': 'MFI-20 \\<13'}, {'measure': 'Anxiety evaluation', 'timeFrame': 'week 4, week 12, week 24', 'description': 'State-Trait Anxiety Inventory (STAI)Y1 and STAI Y2 values'}, {'measure': 'Depression evaluation', 'timeFrame': 'week 4, week 12, week 24', 'description': 'BECK DEPRESSION INVENTORY (BDI-II) values'}, {'measure': 'Quality of life', 'timeFrame': 'week 4, week 12, week 24', 'description': 'Inflammatory Bowel Disease Questionnaire (IBDQ) values'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['iron', 'fatigue', "crohn's disease", 'ulcerative colitis', 'IBD'], 'conditions': ['Chronic Fatigue', 'Inflammatory Bowel Disease']}, 'descriptionModule': {'briefSummary': 'A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron supplementation on chronic fatigue in IBD patients with controlled disease.', 'detailedDescription': 'The study will evaluate a 6 months therapy with intravenous ferric carboxymaltose.\n\nPatients will undergo a 2-5 days screening period and then will be treated every 4 weeks with iron supplementation/placebo.\n\nAt every visit, hematology and blood iron levels will be evaluated. Treatment will be temporarily stopped in case of either Hemoglobin levels above 16 g/dl or ferritin above 800 ng/ml (level decreased to 500 ng/ml in case of Transferrin-Iron Saturation Percentage above 50%).\n\nStudy team will be composed of blinded and unblinded personnel and dedicated infusion devices will be used to ensure the double blinding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Ulcerative Colitis or Crohn's Disease established at least 6 months prior to Day 1 by endoscopy and/or imaging\n* At least 6 months of clinical remission (Harvey Bradshaw Index ≤5; Mayo clinical score ≤ 2)\n* Therapy with mesalamine, immunosuppressors or anti-tumor necrosis factor alpha (TNFα) at stable doses for at least 3 months prior enrollment; steroids are not permitted from 6 months prior baseline\n* Chronic fatigue symptoms (MFI-20\\>13)\n* Iron deficiency: ferritin \\< 100 microg/l or \\< 300 microg/l in case of Transferrin-Iron Saturation Percentage (TSAT) \\<20%\n* Women of childbearing potential must have a negative serum pregnancy test before enrollment.\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Known hypersensibility to active principle or excipients\n* Pregnant or lactating women\n* Clinically active IBD (Harvey Bradshaw Index \\>6; Mayo clinical score \\>3 or C-Reactive Protein \\>2.5 mg/L\n* Renal failure (eGFR\\<60)\n* History of adrenal insufficiency\n* History of autoimmune diseases\n* History of malignancies\n* Depression\n* Any current or recent signs or symptoms of viral infectious diseases\n* Recent psycho-traumatic events\n* Hemoglobin levels \\< 12.5 g/dl (men) or \\<11.5 g/dL (women)"}, 'identificationModule': {'nctId': 'NCT02517151', 'acronym': 'MICI_2011-01', 'briefTitle': 'Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Effects of Iron Therapy in Patients With Chronic Fatigue and IBD', 'orgStudyIdInfo': {'id': '868'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferric carboxymaltose', 'description': '200 mg in normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24.', 'interventionNames': ['Drug: Ferric carboxymaltose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ferric carboxymaltose', 'type': 'DRUG', 'otherNames': ['Ferinject'], 'armGroupLabels': ['Ferric carboxymaltose']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvio Danese, MD, PhD', 'role': 'CONTACT', 'email': 'sdanese@hotmail.com', 'phone': '0039028224', 'phoneExt': '5555'}], 'facility': 'IBD Center', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'Silvio Danese, MD, PhD', 'role': 'CONTACT', 'email': 'IBDclinicaltrials@humanitas.it', 'phone': '+39 02 8224', 'phoneExt': '5555'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}