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.
연구 개요
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10065
- 모병
- Weill Cornell Medicine
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연락하다:
- Jennifer Lentine, DrPH
- 전화번호: (646) 962-9747
- 이메일: Jel2040@med.cornell.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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실험적: 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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활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Median Hemoglobin Level
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of Participants in Clinical Remission According to the Pediatric Crohn's Disease Activity Index (PCDAI)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Robbyn E Sockolow, MD, Weill Medical College of Cornell University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 22-07024996
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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