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

NCT01438372 | Withdrawn Phase 2 DMC

• 2 other identifiers: 1108010039RR11719
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia; Inflammatory Bowel Disease

Keywords

Iron Deficiency Anemia; Inflammatory Bowel Disease; Children

Outcome Measures

Primary Outcomes (2)

• Safety of IV Iron Sucrose

  Safety of IV Iron sucrose is evaluated through timely reporting and thorough description of adverse events. Adverse events related to oral ferrous sulfate will also be reported. Study begins on day of randomization. Iron sucrose is administered on days 1, 7, 14, 21. Follow-up visit is done on day 28 and a follow-up visit or phone call is done on day 49. Oral iron will be taken for 28 days. Patients will be seen in clinic on days 1, 7, 14, 21. With same follow-up as IV iron sucrose.

  Up to 56 days

• Efficacy of IV Iron sucrose as measured by change in Hb measurement

  Efficacy of IV iron sucrose is evaluated through Hb measurement (gm/dl) at baseline and 4 weeks after treatment with intravenous iron sucrose. (increase of 1 gm/dl in 4 weeks is considered significant). This is compared to Hb increase in participants taking oral ferrous sulfate. Study begins on day of randomization. Iron sucrose is administered on days 1, 7, 14, 21. Follow-up visit is done on day 28 and a follow-up visit or phone call is done on day 49. Oral iron will be taken for 28 days. Patients will be seen in clinic on days 1, 7, 14, 21. With same follow-up as IV iron sucrose.

  baseline and up to 4 weeks.

Secondary Outcomes (4)

• determine effect on iron parameters: change in transferrin saturation

  baseline, and up to 56 days

• clinical disease activity

  baseline up to 56 days

• determine effect on iron parameters: change in ferritin levels

  baseline up to 56 days

• determine effect on iron parameters: change in serum iron binding capacity

  baseline up to 56 days

Study Arms (2)

Intravenous iron sucrose arm

EXPERIMENTAL

Drug: Intravenous iron sucrose

Oral ferrous sulfate

ACTIVE COMPARATOR

Drug: Oral ferrous sulfate

Interventions

Intravenous iron sucrose 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.

Also known as: Venofer Luitpold Pharmaceuticals, NDC # 00517-2340-10

Intravenous iron sucrose arm

Oral ferrous sulfate 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.

Also known as: Upsher-Smith ferrous sulfate 325 mg tablets NDC# 00245-0108-11

Oral ferrous sulfate

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead
• Children's Hospital of Michigan: collaborator
• American Regent, Inc.: collaborator

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Inflammatory Bowel Diseases

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Mohammad F El-baba, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief, Pediatric Gastroenterology Division, Children's Hospital of Michigan

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 22, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 7, 2014

Record last verified: 2011-09

Locations

US (1)