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

This study has been withdrawn prior to enrollment.
(The study was terminated prior to enrolling patients as we were unable to secure enough funding to complete the study.)
Sponsor:
Collaborators:
Children's Hospital of Michigan
Luitpold Pharmaceuticals
Information provided by (Responsible Party):
Mohammad El-Baba, Wayne State University
ClinicalTrials.gov Identifier:
NCT01438372
First received: September 14, 2011
Last updated: January 4, 2014
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Iron Deficiency Anemia
Inflammatory Bowel Disease
Drug: Intravenous iron sucrose
Drug: Oral ferrous sulfate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous Iron Sucrose Versus Oral Ferrous Sulfate in Treating Iron Deficiency Anemia in Pediatric Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Safety of IV Iron Sucrose [ Time Frame: Up to 56 days ] [ Designated as safety issue: Yes ]
    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.

  • Efficacy of IV Iron sucrose as measured by change in Hb measurement [ Time Frame: baseline and up to 4 weeks. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • determine effect on iron parameters: change in transferrin saturation [ Time Frame: baseline, and up to 56 days ] [ Designated as safety issue: No ]
    would like to determine change in iron parameters: change in transferrin saturation, ferritin levels, serum iron binding capacity. Study begins on day of randomization. Participants have been identified approximately a week before. 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.

  • clinical disease activity [ Time Frame: baseline up to 56 days ] [ Designated as safety issue: No ]
    to evaluate effects of oral FeSO4 and IV iron sucrose on clinical disease activity. Crohns disease activity will be measured by the Pediatric Crohns Disease Activity Index. Ulcerative colitis disease activity will be measured by Truelove and Witt's classification of severity of ulcerative colitis. Both will be measured at baseline and at 4 weeks. Iron sucrose is administered on days 1, 7, 14, 21. F/u visit is done on day 28 and a f/u visit or phone call is done on day 49. Oral iron will be taken for 28 days. Pts will be seen in clinic on days 1, 7, 14, 21.Same f/u as iron sucrose.

  • determine effect on iron parameters: change in ferritin levels [ Time Frame: baseline up to 56 days ] [ Designated as safety issue: No ]
    would like to determine change in iron parameters: change in transferrin saturation, ferritin levels, serum iron binding capacity. Study begins on day of randomization. Participants have been identified approximately a week before. 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.

  • determine effect on iron parameters: change in serum iron binding capacity [ Time Frame: baseline up to 56 days ] [ Designated as safety issue: No ]
    would like to determine change in iron parameters: change in transferrin saturation, ferritin levels, serum iron binding capacity. Study begins on day of randomization. Participants have been identified approximately a week before. 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.


Enrollment: 0
Study Start Date: November 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous iron sucrose arm Drug: 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.
Other Name: Venofer Luitpold Pharmaceuticals, NDC # 00517-2340-10
Active Comparator: Oral ferrous sulfate 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.
Other Name: Upsher-Smith ferrous sulfate 325 mg tablets NDC# 00245-0108-11

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

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438372

Locations
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Children's Hospital of Michigan
Luitpold Pharmaceuticals
Investigators
Principal Investigator: Mohammad F El-baba, MD Wayne State University
  More Information

No publications provided

Responsible Party: Mohammad El-Baba, Division Chief, Pediatric Gastroenterology Division, Children's Hospital of Michigan, Wayne State University
ClinicalTrials.gov Identifier: NCT01438372     History of Changes
Other Study ID Numbers: 1108010039, RR11719
Study First Received: September 14, 2011
Last Updated: January 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Wayne State University:
Iron Deficiency Anemia
Inflammatory Bowel Disease
Children

Additional relevant MeSH terms:
Anemia
Inflammatory Bowel Diseases
Intestinal Diseases
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric oxide, saccharated
Ferric Compounds
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014