Iron Deficient Anemia
Conditions
Interventions
Treatment group:Ferric carboxymaltose
Control group:Iron sucrose
Sponsors
Hematology department, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health
Eligibility
Sex/Gender
All
Age
0.5 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) Children = 1 year and =18 years; 2) Confirmed IDA based on clinical manifestations, hematology, iron metabolism, etc.; 3) No prior history of intravenous iron therapy; 4) Fulfillment of any of the following criteria prior to enrollment: (1) Patients who cannot or are unwilling to tolerate gastrointestinal adverse reactions of oral iron supplements, or patients with existing gastrointestinal disorders that may exacerbate the adverse reactions of oral iron supplements; (2) Patients who themselves and/or whose guardians are willing to receive intravenous iron therapy; (3) Persistent bleeding, which exceeds the ability of oral iron supplements to meet iron supplementation demands (e.g., serious uterine bleeding, mucosal capillary dilation); (4) Anatomical or physiological conditions affecting the absorption of oral iron; (5) Concomitant inflammation interfering with iron metabolism homeostasis; (6) Surgery with an expected blood loss of > 500 ml, or ID patients who require surgery within 6 weeks; 5) No contraindications for drug therapy; 6) Commitment to long-term follow-up visits to the diagnosis and treatment center; 7) Parents/guardians of selected children patients voluntarily sign the Informed Consent Form
Exclusion criteria
Exclusion criteria: 1) Prior use of intravenous iron therapy; 2) Patients with sepsis, since iron can promote microbial growth; 3) Patients with hypophosphataemia; 4) Hypersensitivity to iron supplements; 5) Any significantly abnormal concomitant disease or mental illness that affects the patient's life safety and compliance, informed consent, study participation, followup, or interpretation of results; 6) The child patient or his/her guardian cannot be followed and shows poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate;Icidence of adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay;Total expenditures ; | — |
Countries
China
Contacts
Public Contactjin jiang
Hematology department, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health
Outcome results
None listed