Status:
WITHDRAWN
IV Iron Sucrose vs Oral FeSO4 in Treating IDA in Pediatric IBD
Lead Sponsor:
Wayne State University
Collaborating Sponsors:
Children's Hospital of Michigan
American Regent, Inc.
Conditions:
Iron Deficiency Anemia
Inflammatory Bowel Disease
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety and efficacy of intravenous iron sucrose in comparison to oral ferrous sulfate in improving iron deficiency anemia in children with inflammatory bowel...
Detailed Description
Iron deficiency anemia (IDA) is very common among children with inflammatory bowel disease. Causes in this population are multi-factorial, including decreased absorption due to intestinal disease, inc...
Eligibility Criteria
Inclusion
- IBD Diagnosis.
- IDA (defined as a hemoglobin (Hb) concentration of ≤10.5 g/dL females) or Hb ≤11.0 g/dL (males) and Mean Corpuscular volume (MCV) \< 77 \[22\] plus transferrin saturation (TSAT) \< 20% and/or serum ferritin concentration less than 25 µg/L)
- 12- 17 years old males or females.
- A signed parental permission and assent. Assent is not required in those below 13 years of age.
- We will be including those who have received iron therapy in the past even if they have developed adverse reactions, as long as they have not been anaphylactic. Participants should have been "iron free" (no iron therapy - oral or IV) for two weeks prior to start of study.
Exclusion
- Anemia other than IDA e.g hemolytic anemia, anemia due to Vitamin B12/Folic acid deficiency.
- Blood transfusion or iron supplementation 2 two weeks or less before starting the study.
- Iron overload.
- Renal disease - on medications such as diuretics or blood pressure lowering medications. On renal replacement therapy.
- Severe reactive airway disease - classified as severe/high-risk asthma
- Significant cardiac disease - on cardiac medications, including symptomatic congenital cardiac anomalies or with arrhythmias.
- Anaphylaxis/hypersensitivity reaction to ferrous sulfate and/or iron sucrose
- Pregnant and nursing women. A serum pregnancy test will be performed at the start of the study and on days 1, 14, and 28. Patients aged 12 years of age and are found to be pregnant are considered victims of child abuse and will be reported to child protective services and the appropriate authorities.
- Any other severe concurrent illness.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01438372
Start Date
November 1 2011
End Date
March 1 2012
Last Update
January 7 2014
Active Locations (1)
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1
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201