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

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, increased losses due to bleeding from the gastrointestinal (GI) tract,
and poor nutrition. IDA can cause significant impaired physical activity and is associated
with developmental and cognitive abnormalities in children and adolescents. Oral ferrous
sulfate has been traditionally used to treat iron deficiency anemia, but this is associated
with limitations. Studies have shown that only a part of the oral iron is absorbed and the
non-absorbed iron salts can be toxic to the intestinal mucosa, and was also theorized to be
capable of activating the Inflammatory Bowel Disease (IBD). Use of intravenous iron sucrose
has been used in other populations with iron deficiency anemia such as those with chronic
kidney disease and children with significant blood loss after spinal surgery. The aim of
this study is to determine the safety and efficacy of intravenous iron sucrose in improving
iron deficiency anemia in children with inflammatory bowel disease (in comparison to oral
ferrous sulfate).

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.