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

NCT ID: NCT01438372

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-03-31

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).

Conditions

Iron Deficiency Anemia; Inflammatory Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous iron sucrose arm

Group Type: EXPERIMENTAL

Intravenous iron sucrose

Intervention Type: DRUG

Intravenous iron sucrose will be administered on days 1, 7, 14, and 21 using the formula: Total dose: (normal Hb for age - initial Hb)/100 x blood volume (ml) x 3.4 x 1.5. First dose will be infused over 30 minutes, with subsequent doses administered over 15 minutes if no reactions encountered.

Oral ferrous sulfate

Group Type: ACTIVE_COMPARATOR

Oral ferrous sulfate

Intervention Type: DRUG

Oral ferrous sulfate will be administered at 3 mg/kg/day divided into 2 doses for 28 days. A tablet form of ferrous sulfate (325 mg with 65 mg of elemental iron per tablet) will be used.

Interventions

Intravenous iron sucrose

Intravenous iron sucrose will be administered on days 1, 7, 14, and 21 using the formula: Total dose: (normal Hb for age - initial Hb)/100 x blood volume (ml) x 3.4 x 1.5. First dose will be infused over 30 minutes, with subsequent doses administered over 15 minutes if no reactions encountered.

Intervention Type: DRUG

Oral ferrous sulfate

Oral ferrous sulfate will be administered at 3 mg/kg/day divided into 2 doses for 28 days. A tablet form of ferrous sulfate (325 mg with 65 mg of elemental iron per tablet) will be used.

Intervention Type: DRUG

Other Intervention Names

Venofer Luitpold Pharmaceuticals, NDC # 00517-2340-10; Upsher-Smith ferrous sulfate 325 mg tablets NDC# 00245-0108-11

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Michigan

OTHER

Sponsor Role: collaborator

American Regent, Inc.

INDUSTRY

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Mohammad El-Baba

Division Chief, Pediatric Gastroenterology Division, Children's Hospital of Michigan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad F El-baba, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Children's Hospital of Michigan

Detroit, Michigan, United States

Countries

United States

Other Identifiers

RR11719

Identifier Type: OTHER

Identifier Source: secondary_id

1108010039

Identifier Type: -

Identifier Source: org_study_id