protocolSection identificationModule nctId: NCT06366698, orgStudyIdInfo id: 23-55, briefTitle: Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia, acronym: IDA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-21, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Arrowhead Regional Medical Center, class: OTHER, descriptionModule briefSummary: This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded., conditionsModule conditions: Iron Deficiency Anemia of Pregnancy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Patients are initially randomized to either PO or IV iron, after the initial 4-week treatment patients in the PO iron group can switch to IV iron if labs continue to show persist iron deficiency anemia., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 900, type: ESTIMATED, armsInterventionsModule interventions name: Venofer 200 MG Per 10 ML Injection, interventions name: Ferrous sulfate, outcomesModule primaryOutcomes measure: Hemoglobin difference, primaryOutcomes measure: Ferritin difference, primaryOutcomes measure: Delivery Hemoglobin, primaryOutcomes measure: Rates of blood transfusion, primaryOutcomes measure: Symptoms, secondaryOutcomes measure: Preterm delivery, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Birthweight, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arrowhead Regional Medical Center, status: RECRUITING, city: Colton, state: California, zip: 92324, country: United States, contacts name: Guillermo Valenzuela, MD, role: CONTACT, phone: 909-580-4145, email: jvalenzuelar@me.com, contacts name: Tina M Bui, DO, role: PRINCIPAL_INVESTIGATOR, contacts name: Kristina Roloff, DO, role: SUB_INVESTIGATOR, contacts name: Guillermo Valenzuela, MD, role: SUB_INVESTIGATOR, contacts name: Lily Zhu, DO, role: SUB_INVESTIGATOR, contacts name: Phoebe Jen, DO, role: SUB_INVESTIGATOR, contacts name: Mary Tsaturian, MD, role: SUB_INVESTIGATOR, geoPoint lat: 34.0739, lon: -117.31365, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-21, uploadDate: 2024-04-10T14:44, filename: ICF_000.pdf, size: 165063, hasResults: False