Clinical trial NCT01438372: IV Iron Sucrose vs Oral FeSO4 in Treating IDA in Pediatric IBD
Official title: Intravenous Iron Sucrose Versus Oral Ferrous Sulfate in Treating Iron Deficiency Anemia in Pediatric Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Iron Deficiency Anemia
Inflammatory Bowel Disease
Keywords: Iron Deficiency Anemia
Inflammatory Bowel Disease
Children
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Michigan
name: American Regent, Inc.
First posted: 2011-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 disease.

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, 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).

Eligibility 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.

Primary outcomes:
measure: Safety of IV Iron Sucrose
timeFrame: Up to 56 days
measure: Efficacy of IV Iron sucrose as measured by change in Hb measurement
timeFrame: baseline and up to 4 weeks.
Secondary outcomes:
measure: determine effect on iron parameters: change in transferrin saturation
timeFrame: baseline, and up to 56 days
measure: clinical disease activity
timeFrame: baseline up to 56 days
measure: determine effect on iron parameters: change in ferritin levels
timeFrame: baseline up to 56 days
measure: determine effect on iron parameters: change in serum iron binding capacity
timeFrame: baseline up to 56 days
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
Study officials:
affiliation: Wayne State University
name: Mohammad F El-baba, MD
role: PRINCIPAL_INVESTIGATOR
References: