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.

Study Overview

• Status: Recruiting
• Conditions: Crohn's Disease; Iron Deficiency Anemia
• Intervention / Treatment: Drug: Iron (ferrous sulfate)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Jennifer Lentine, DrPH; Phone Number: (646) 962-9747; Email: Jel2040@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Iron (ferrous sulfate); Iron supplementation for treatment of iron deficiency anemia. The dose, schedule, and route are determined by the assigned study arm.
Experimental: Low-Dose-Every-Other-Day Oral Iron; Participants randomized to this arm receive oral iron at 1-2 mg/kg every other day	Drug: Iron (ferrous sulfate); Iron supplementation for treatment of iron deficiency anemia. The dose, schedule, and route are determined by the assigned study arm.
Active Comparator: 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.	Drug: Iron (ferrous sulfate); Iron supplementation for treatment of iron deficiency anemia. The dose, schedule, and route are determined by the assigned study arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Hemoglobin Level	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)	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.
Median Serum Iron Level	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.
Median Iron Saturation	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.
Median Ferritin Level	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants in Clinical Remission According to the Pediatric Crohn's Disease Activity Index (PCDAI)	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.
General Wellbeing Score	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	Number of participants with fatigue documented as an adverse event during study follow-up.	From enrollment through up to 3 years

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Robbyn E Sockolow, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): March 13, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: November 3, 2026
• First Submitted That Met QC Criteria: November 3, 2026
• First Posted (Actual): November 9, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 3, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hematologic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Crohn Disease; Anemia, Iron-Deficiency; Organic Chemicals; Carbohydrates; Coordination Complexes; Polysaccharides; Glucans; Dextrans; Iron-Dextran Complex
• Other Study ID Numbers: 22-07024996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No