Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:27 AM
Study NCT ID:
NCT07366502
Status:
RECRUITING
Last Update Posted:
2026-01-27
First Post:
2025-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposomal vs Conventional Oral Iron After Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-24', 'size': 56213, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-12-24T09:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2025-12-24', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hemoglobin Level From Baseline to Week 24', 'timeFrame': '24 weeks', 'description': 'The change in hemoglobin concentration will be calculated as the absolute difference between baseline and week 24 values.'}], 'secondaryOutcomes': [{'measure': 'Change in Serum Ferritin Level From Baseline to Week 24', 'timeFrame': '24 weeks', 'description': 'Absolute change in serum ferritin concentration from baseline to week 24.'}, {'measure': 'Change in Transferrin Saturation (TSAT) From Baseline to Week 24', 'timeFrame': '24 weeks', 'description': 'Absolute change in transferrin saturation percentage from baseline to week 24.'}, {'measure': 'Change in Serum Iron Level From Baseline to Week 24', 'timeFrame': '24 weeks', 'description': 'Absolute change in serum iron concentration from baseline to week 24.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iron deficiency anemia', 'Post-Bariatric surgery', 'Complications', 'Laparoscopic Sleeve Gastrectomy', 'Liposomal ıron', 'Conventional ıron'], 'conditions': ['İron Deficiency Anemia', 'Liposomal Iron Replacement', 'Conventional Iron Replacement']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/38156148/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Low-dose liposomal iron (17-34 mg elemental/day) was compared with standard conventional oral iron (100-200mg elemental/day) in the treatment of iron deficiency anemia following sleeve gastrectomy. Liposomal iron provided superior hematological improvement and gastrointestinal tolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age between 18 and 65 years\n* History of laparoscopic sleeve gastrectomy performed at least 6 months prior to enrollment\n* Diagnosis of iron deficiency anemia, defined as:\n* Hemoglobin \\<12 g/dL in women or \\<13 g/dL in men, and\n* Serum ferritin \\<30 ng/mL or transferrin saturation (TSAT) \\<20%\n* Mild to moderate anemia (hemoglobin ≥9 g/dL)\n* Ability to take and swallow oral medications\n* Willingness to participate and provide written informed consent Exclusion Criteria\n* Active gastrointestinal disease (e.g., inflammatory bowel disease, peptic ulcer disease, or gastrointestinal bleeding)\n* Chronic kidney disease with estimated GFR \\<30 mL/min/1.73 m²\n* Use of oral or parenteral iron, vitamin B12, or folate supplementation within the previous 3 months\n* Iron overload or hemochromatosis (serum ferritin \\>300 ng/mL)\n* Known allergy or intolerance to iron preparations\n* Active malignancy\n* Pregnancy or breastfeeding\n* Known hemoglobinopathies (e.g., thalassemia, sickle cell disease)\n* Blood transfusion within the previous 1 month\n* Cognitive or psychiatric disorder interfering with study participation or protocol adherence'}, 'identificationModule': {'nctId': 'NCT07366502', 'acronym': 'anemia', 'briefTitle': 'Liposomal vs Conventional Oral Iron After Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Goztepe Prof Dr Suleyman Yalcın City Hospital'}, 'officialTitle': 'Comprehensive Hematological and Biochemical Comparison of Low-Dose Liposomal Iron Versus Standard-Dose Conventional Oral Iron in Iron Deficiency Anemia Following Sleeve Gastrectomy: A Prospective, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2025-GOSEK-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 Title: Liposomal Iron (Group LD)', 'description': 'Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving oral liposomal iron.', 'interventionNames': ['Drug: Liposomal Iron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 Title: Conventional Iron (Group KD)', 'description': 'Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving conventional oral ferrous iron preparations.', 'interventionNames': ['Drug: conventional oral iron']}], 'interventions': [{'name': 'Liposomal Iron', 'type': 'DRUG', 'description': 'Oral liposomal iron capsules containing 17 iron per capsule, adminstered as 2 capsules daily, taken independently of meals for 6 months.', 'armGroupLabels': ['Arm 1 Title: Liposomal Iron (Group LD)']}, {'name': 'conventional oral iron', 'type': 'DRUG', 'description': 'oral ferrous iron preparations (ferrous sulfate, ferrous fumarate, or ferrous gluconate), each providing 100-200 mg elemental iron once daily, administered on an empty stomatch with 200 mg vitamin c for 6 months.', 'armGroupLabels': ['Arm 2 Title: Conventional Iron (Group KD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34630', 'city': 'Istanbul', 'state': 'kadıköy', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gürhan Baş, Prof.', 'role': 'CONTACT', 'email': 'medeniyetuniversity@medeniyet.edu.tr', 'phone': '+902166065200'}], 'facility': 'Goztepe Prof.Dr. Suleyyman Yalçın City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Medeni Sermet, assoc.prof', 'role': 'CONTACT', 'email': 'sermetmedeni@gmail.com', 'phone': '+905072367020'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'We can share anonymized demographic and laboratory data upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medeni Şermet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assoc.prof., MD.', 'investigatorFullName': 'Medeni Şermet', 'investigatorAffiliation': 'Goztepe Prof Dr Suleyman Yalcın City Hospital'}}}}