NCT07925450 Iron Treatment for Iron Deficiency Anemia in Children and Young Adults With Crohn's Disease
| NCT ID | NCT07925450 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-09-13 |
| Primary Completion | 2029-03-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2023-09-13 with a primary completion date of 2029-03-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Robbyn E Sockolow, MD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT07925450 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 21 Years, studying Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07925450 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07925450 currently recruiting?
Yes, NCT07925450 is actively recruiting participants. Visit ClinicalTrials.gov or contact Weill Medical College of Cornell University to inquire about joining.
Where is the NCT07925450 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07925450 clinical trial?
NCT07925450 is sponsored by Weill Medical College of Cornell University. The principal investigator is Robbyn E Sockolow, MD at Weill Medical College of Cornell University. The trial plans to enroll 150 participants.
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