Iron Treatment for Iron Deficiency Anemia in Children and Young Adults With Crohn's Disease
Developing and Validating a Predictive Model for the Management of Iron Deficiency Anemia in Pediatric Crohn's Disease Through Analysis of Microbiome and Patient Laboratory Data
Children and young adults with Crohn's disease may develop iron deficiency anemia, a condition in which low iron levels reduce the number of healthy red blood cells. This study aims to develop and test a model to help identify which iron treatment approached are most effective for these patients. Researchers will examine laboratory results, disease activity, treatment information, and information about bacteria in the digestive tract. Participants will be followed over time, and questionnaires will assess iron supplement use and related symptoms. The findings may help guide iron treatment for children and young adults with Crohn's disease.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习地点
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New York
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New York、New York、美国、10065
- 招聘中
- Weill Cornell Medicine
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接触：
- Jennifer Lentine, DrPH
- 电话号码：(646) 962-9747
- 邮箱：Jel2040@med.cornell.edu
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female
- 3 to 21 years of age
- Biopsy confirmed Crohns disease involving gastric, duodenal, and/or jejunal mucosa
- Quiescent Crohns disease, assessed by histopathology, CRP, ESR, and PCDAI scores
- Iron deficiency anemia, defined as hemoglobin or transferrin saturation below age-defined norms and/or MCV <80.
Exclusion Criteria:
- antibiotic use with 6 weeks of endoscopic evaluation
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Standard-Care Daily Oral Iron
Participants randomized to this arm receive oral iron at 3 - 6 mg/kg per day, as described in the protocol's standard-of-care regimen |
Iron supplementation for treatment of iron deficiency anemia. The dose, schedule, and route are determined by the assigned study arm. |
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实验性的：Low-Dose-Every-Other-Day Oral Iron
Participants randomized to this arm receive oral iron at 1-2 mg/kg every other day |
Iron supplementation for treatment of iron deficiency anemia. The dose, schedule, and route are determined by the assigned study arm. |
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有源比较器：Physician-Directed Iron Treatment
Participants enter this arm without randomization and receive iron supplementation at the dose, schedule, and formulation selected by their treating physician if the physician feels another method/dose of iron is more appropriate for the patient than the Standard-Care Daily Oral Iron arm or the Low-Dose-Every-Other-Day Oral Iron arm. |
Iron supplementation for treatment of iron deficiency anemia. The dose, schedule, and route are determined by the assigned study arm. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Median Hemoglobin Level
大体时间：At routine follow-up visits typically every 4 to 12 weeks, for up to 3 years after enrollment.
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Hemoglobin levels assessed using routine-care laboratory results. Values will be evaluated relative to age- and sex-specific reference ranges. Median hemoglobin level and interquartile range will be reported separately for each treatment arm at each assessment time point. |
At routine follow-up visits typically every 4 to 12 weeks, for up to 3 years after enrollment.
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Median MCV (Mean Corpuscular Volume)
大体时间：At routine follow-up visits, typically every 4-12 weeks, for up to 3 years after enrollment.
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Mean corpuscular volume (MCV) assessed using routine-care laboratory results. The protocol defines normalization as MCV greater than 80 fL. Median MCV and interquartile range will be reported separately for each treatment arm at each assessment time point. |
At routine follow-up visits, typically every 4-12 weeks, for up to 3 years after enrollment.
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Median Serum Iron Level
大体时间：Approximately every 6 months during follow-up, for up to 3 years after enrollment.
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Serum iron assessed using routine-care laboratory results. Median serum iron level and interquartile range will be reported separately for each treatment arm at each assessment time point. |
Approximately every 6 months during follow-up, for up to 3 years after enrollment.
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Median Iron Saturation
大体时间：Approximately every 6 months during follow-up, for up to 3 years after enrollment.
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Iron Saturation assessed using routine-care laboratory results. Median iron saturation and interquartile range will be reported separately for each treatment arm at each assessment time point. |
Approximately every 6 months during follow-up, for up to 3 years after enrollment.
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Median Ferritin Level
大体时间：Approximately every 6 months during follow-up for up to 3 years.
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Ferritin assessed using routine-care laboratory results. Median ferritin level and interquartile range will be reported separately for each treatment arm at each assessment time point. |
Approximately every 6 months during follow-up for up to 3 years.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of Participants in Clinical Remission According to the Pediatric Crohn's Disease Activity Index (PCDAI)
大体时间：At routine follow-up visits, typically every 4 to 12 weeks, for up to 3 years after enrollment.
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Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score of 0 to 10, as documented by the treating provider in the medical record. The proportion of participants meeting the definition of clinical remission will be reported at each assessment time point. |
At routine follow-up visits, typically every 4 to 12 weeks, for up to 3 years after enrollment.
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General Wellbeing Score
大体时间：At routine follow-up visits, typically every 4 to 12 weeks, for up to 3 years after enrollment
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General wellbeing assessed using the general wellbeing component of the Pediatric Crohn's Disease Activity Index (PCDAI), as documented by the treating provider in the medical record. Scores are 0, 5, or 10, with higher scores indicating worse well-being. A score of 0 indicates well-being with no activity limitations, and a score of 10 indicates very poor wellbeing with frequent activity limitations. Median scores and interquartile ranges will be reported separately for each treatment arm at each assessment time point. |
At routine follow-up visits, typically every 4 to 12 weeks, for up to 3 years after enrollment
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Number of Participants with Fatigue
大体时间：From enrollment through up to 3 years
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Number of participants with fatigue documented as an adverse event during study follow-up. |
From enrollment through up to 3 years
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合作者和调查者
调查人员
- 首席研究员：Robbyn E Sockolow, MD、Weill Medical College of Cornell University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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