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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10065
- 募集
- Weill Cornell Medicine
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コンタクト：
- Jennifer Lentine, DrPH
- 電話番号：(646) 962-9747
- メール：Jel2040@med.cornell.edu
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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. |
|
実験的：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. |
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Median Hemoglobin Level
時間枠：At routine follow-up visits typically every 4 to 12 weeks, for up to 3 years after enrollment.
|
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.
|
|
Median MCV (Mean Corpuscular Volume)
時間枠：At routine follow-up visits, typically every 4-12 weeks, for up to 3 years after enrollment.
|
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
時間枠：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
時間枠：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
時間枠：Approximately every 6 months during follow-up for up to 3 years.
|
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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants in Clinical Remission According to the Pediatric Crohn's Disease Activity Index (PCDAI)
時間枠：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
時間枠：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
|
|
Number of Participants with Fatigue
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Robbyn E Sockolow, MD、Weill Medical College of Cornell University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 22-07024996
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