Oxidative Stress and Inflammation Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Extra iron may not be necessary in the treatment of iron deficiency anemia in Crohn's Disease;Oxidative Stress and Inflammation may be Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jinling Hospital, China
• Collaborator: Ministry of Health, China
• Treatments: Epoetin Alfa; Iron

Criteria

Inclusion Criteria:

• Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria

• Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.

• Subjects should have a CDAI score <150 at week 0

• Able to swallow tablets

• Are capable of providing written informed consent and obtained at the time of enrollment

• Willing to adhere to the study visit schedule and other protocol requirements.

• Subjects should have the hemoglobin： male patients<130g/L，female patients<120g/L.

Exclusion Criteria:

• Bacterial,viral or other microbial infection(including HIV)

• Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.

• Previous or current use of infliximab.

• current use of prescription doses or chronic/frequent use of NSAIDs

• Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted)

• History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)

• History of abnormal liver function tests, including AST or ALT >1.5 times upper limit of normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5 mg/dL at screening (or within the previous 6 months, if known)

• History of malignancy

• Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.

• Participation in other clinical trial within the past 6 months