Recruiting
Phase 4

Iron Treatment

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07925450

Conditions

Crohn's Disease

Iron Deficiency Anemia

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Not accepted

Interventions

Iron (ferrous sulfate)

Study Details

Brief summary:

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.

Conditions

Crohn's Disease

Iron Deficiency Anemia

Study ID

NCT07925450

Start date

Sep 13, 2023

Status verified date

Nov, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Mar 13, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

experimental: Low-Dose-Every-Other-Day Oral Iron

Participants randomized to this arm receive oral iron at 1-2 mg/kg every other day

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.

Interventions

Iron (ferrous sulfate)

Iron supplementation for treatment of iron deficiency anemia. The dose, schedule, and route are determined by the assigned study arm.

Primary outcome measure

  • Median Hemoglobin Level [ Time Frame: At routine follow-up visits typically every 4 to 12 weeks, for up to 3 years after enrollment. ]
  • Median MCV (Mean Corpuscular Volume) [ Time Frame: At routine follow-up visits, typically every 4-12 weeks, for up to 3 years after enrollment. ]
  • Median Serum Iron Level [ Time Frame: Approximately every 6 months during follow-up, for up to 3 years after enrollment. ]
  • Median Iron Saturation [ Time Frame: Approximately every 6 months during follow-up, for up to 3 years after enrollment. ]
  • Median Ferritin Level [ Time Frame: Approximately every 6 months during follow-up for up to 3 years. ]

Central Contacts and Locations

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Jennifer Lentine, DrPH

(646) 962-9747Jel2040@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.