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

January 4, 2014 updated by: Mohammad El-Baba, Wayne State University

Intravenous Iron Sucrose Versus Oral Ferrous Sulfate in Treating Iron Deficiency Anemia in Pediatric Inflammatory Bowel Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Upsher-Smith ferrous sulfate 325 mg tablets NDC# 00245-0108-11

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of IV Iron Sucrose
Time Frame: Up to 56 days
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
Time Frame: baseline and up to 4 weeks.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
determine effect on iron parameters: change in transferrin saturation
Time Frame: baseline, and up to 56 days
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.
baseline, and up to 56 days
clinical disease activity
Time Frame: baseline up to 56 days
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.
baseline up to 56 days
determine effect on iron parameters: change in ferritin levels
Time Frame: baseline up to 56 days
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.
baseline up to 56 days
determine effect on iron parameters: change in serum iron binding capacity
Time Frame: baseline up to 56 days
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.
baseline up to 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wayne State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital of Michigan
American Regent, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohammad F El-baba, MD, Wayne State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1108010039
  • RR11719 (OTHER: Detroit Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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