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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01823029
• Date of registration: 25/03/2013
• Prospective Registration: No
• Primary sponsor: Jinling Hospital, China
• Public title: Oxidative Stress and Inflammation Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia CD-AT1
• Date of first enrolment: November 2012
• Target sample size: 387
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01823029
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: wei ming zhu, PhD,MD
• Affiliation: General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: injection of iron

Drug: enteral nutrition.

Drug: erythropoietin

Primary Outcome(s)

haemoglobin raise to norm or not. [Time Frame: at 0 week, the first week, the second week, the third week, the fourth week]

Secondary Outcome(s)

relapse of anaemia [Time Frame: 12 weeks after treatment]

The change of haematological inflammation marker(CRP,ESR,IL-10,IL-6,TNF-a,IL-1ß) [Time Frame: at 0 week, the first week, the second week, the third week, the fourth week]

The change of haematological oxidative stress indicators(SOD,GSH-px and MDA) [Time Frame: at 0 week, the first week, the second week, the third week, the fourth week]

The change of patients'IBDQ and CDAI. [Time Frame: at 0 week and the fourth week]

Secondary ID(s)

CD-AT1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ministry of Health, China