Intravenous Iron Sucrose Versus Oral Ferrous Sulfate in Treating Iron Deficiency Anemia in Pediatric Inflammatory Bowel Disease
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety of IV Iron Sucrose
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Intravenous iron sucrose arm
干预措施: Intravenous iron sucrose (Drug)
Oral ferrous sulfate
干预措施: Oral ferrous sulfate (Drug)
结局指标
主要结局
Safety of IV Iron Sucrose
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Mohammad El-Baba
Division Chief, Pediatric Gastroenterology Division, Children's Hospital of Michigan
Wayne State University