IV Iron Sucrose vs Oral FeSO4 in Treating IDA in Pediatric IBD

• Status: Withdrawn
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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 disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wayne State University
• Collaborators: American Regent, Inc.; Children's Hospital of Michigan; Luitpold Pharmaceuticals
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

1. IBD Diagnosis.

2. 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)

3. 12- 17 years old males or females.

4. A signed parental permission and assent. Assent is not required in those below 13 years of age.

5. 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 Criteria:

1. Anemia other than IDA e.g hemolytic anemia, anemia due to Vitamin B12/Folic acid deficiency.

2. Blood transfusion or iron supplementation 2 two weeks or less before starting the study.

3. Iron overload.

4. Renal disease - on medications such as diuretics or blood pressure lowering medications. On renal replacement therapy.

5. Severe reactive airway disease - classified as severe/high-risk asthma

6. Significant cardiac disease - on cardiac medications, including symptomatic congenital cardiac anomalies or with arrhythmias.

7. Anaphylaxis/hypersensitivity reaction to ferrous sulfate and/or iron sucrose

8. 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.

9. Any other severe concurrent illness.