Status:
COMPLETED
Oxidative Stress and Inflammation Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia
Lead Sponsor:
Jinling Hospital, China
Collaborating Sponsors:
Ministry of Health, China
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Detailed Description
Anemia is one of the commonest extra-intestinal manifestations of Crohn's disease (CD) with a prevalence ranging from 6.2% up to 73.7%.Compared with other complications,it has been subestimated and re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT01823029
Start Date
November 1 2012
End Date
November 1 2013
Last Update
November 27 2013
Active Locations (1)
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1
General Surgery Institute,Jinling Hospital
Nanjing, Jiangsu, China, 210000