Inflammatory bowel disease
Conditions
Interventions
Intervention group:iron isomaltoside
Control group:traditional iron supplements
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age=18 years old, inclusive. 2. The subject is newly diagnosed with IBD and IDA between January 1, 2023 and December 31, 2023. The diagnosis of IBD is in accordance with "The consensus on diagnosis and treatment of inflammatory bowel diseases in 2018"; The diagnosis of IDA is in accordance with following criterion: a) Hb<10g/dL; b) Serum ferritin<100ug/L. 3. The subject accepts iron treatment after diagnosis. 4. The subject volunteers to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Ambiguous or changed diagnosis during follow-up. 2. The subject has diseases that may also cause anemia, such as autoimmune disease, blood disease, urinary disease, digestive disease, tumor, or surgery within 8 weeks. 3. The subject has diseases with iron overload or impaired iron utilization (e.g., hemochromatosis). 4. The subject has allergy to iron isomaltoside or other intravenous/oral iron supplements. 5. The subject has a planned surgery with excessive blood loss during the study. 6. The subject who has participated in any other clinical studies within 3 months before enrollment. 7. The subject is considered as disadvantaged groups, including subjects who are critically ill, who have psychiatric disorders or cognitive impairment, or who are pregnant or juveniles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iron;Serum ferritin;Transferrin saturation;hemoglobin;CRP;ESR; | — |
Secondary
| Measure | Time frame |
|---|---|
| MCV;MCH;MCHC;HCT;RDW; | — |
Countries
China
Contacts
Public ContactQian Cao
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed