Oxidative Stress and Inflammation Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia (CD-AT1)

November 26, 2013 updated by: Zhu Weiming, Jinling Hospital, China
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 received less attention from gastroenterologists, although,which is frequently associated with a reduced quality of life.What's more,there were not appropriate strategies for the adequate treatment of anaemia in CD either.

The anaemia in CD is caused by several factors, such as iron, folic acid or B12 deficiency, treatment with immunosuppressive drugs or sulfasalazine-induced hemolysis, and anemia of chronic disease, of which iron deficiency was one of the most important mechanisms. Additionally, erythropoietin(EPO) levels in chronic disease anemia are generally higher than in normal subjects.However, in CD anemic patients this EPO increase is inadequate in relation to the degree of anemia.Thus, in the treatment of iron deficiency anemia (IDA) in CD,EPO and iron supplementation are very common.Because intravenous(IV) iron is more effective and better tolerated than oral iron and is to be considered in patients with severe anemia (Hb<10.0 g/dL), with intolerance or inadequate response to oral iron and/or those with active IBD. Intravenous iron administration is the route of choice when simultaneous treatment with erythropoiesis stimulat-ing agents (ESA) is considered.

But parenteral iron formulations have potential toxic effects such as triggering oxidative reactions and inflammatory reactions that may be very disadvantageous to CD patients. Free iron may provoke formation of free oxygen radicals. Although complex carbohydrate structures that cover free iron may alleviate this oxidative and inflammatory potential,it cannot be completely blocked. These suggest that parenteral iron could be a "double-edged sword" with the hematologic benefits (increase in hemoglobin [Hb]) on the one hand, and with the risk of enhancement of systemic inflammation and oxidative stress on the other.

Although the oxidative potential of intravenous iron (IVI) has been studied extensively,there have been no studies about the effects of parenteral iron therapy on oxidative stress and inflammatory markers in the CD population. In this study, we compared different types and schedules of iron compounds for their effects on serum inflammatory-oxidative stress indices.

Study Type

Interventional

Enrollment (Actual)

387

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • General Surgery Institute,Jinling Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: erythropoietin,injection of iron and enteral nutrition
The patients receive treatment of erythropoietin,injection of iron and enteral nutrition.
Drug: erythropoietin
Drug: enteral nutrition.
Drug: injection of iron
EXPERIMENTAL: erythropoietin and enteral nutrition.
The patients receive treatment of erythropoietin and enteral nutrition.
Drug: erythropoietin
Drug: enteral nutrition.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The change of haematological inflammation marker(CRP,ESR,IL-10,IL-6,TNF-ａ,IL-1β)
Time Frame: at 0 week, the first week, the second week, the third week, the fourth week
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
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
at 0 week and the fourth week
relapse of anaemia
Time Frame: 12 weeks after treatment
12 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Collaborators

Ministry of Health, China

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (ESTIMATE)

April 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-AT1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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