IV Iron Sucrose vs Oral FeSO4 in Treating IDA in Pediatric IBD
- Conditions
- Iron Deficiency AnemiaInflammatory Bowel Disease
- Interventions
- Registration Number
- NCT01438372
- Lead Sponsor
- Wayne State University
- 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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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)
- 12- 17 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral ferrous sulfate Oral ferrous sulfate - Intravenous iron sucrose arm Intravenous iron sucrose -
- Primary Outcome Measures
Name Time Method Safety of IV Iron Sucrose 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.
Efficacy of IV Iron sucrose as measured by change in Hb measurement 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.
- Secondary Outcome Measures
Name Time Method determine effect on iron parameters: change in transferrin saturation 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.
clinical disease activity 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.
determine effect on iron parameters: change in ferritin levels 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.
determine effect on iron parameters: change in serum iron binding capacity 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.
Trial Locations
- Locations (1)
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States