A Phase 4 interventional study of Iron (ferrous sulfate) in Crohn's Disease and Iron Deficiency Anemia, sponsored by Weill Medical College of Cornell University. Recruiting at 1 site in United States. Open to participants aged 3 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Treatment
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.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 150 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Participants randomized to this arm receive oral iron at 1-2 mg/kg every other day
Drug: Iron (ferrous sulfate)
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.
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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Approximately every 6 months during follow-up for up to 3 years.
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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment through up to 3 years
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Mar 2029, 66 months after the start.
Of 54 non-industry phase 4 interventional studies under Crohn Disease, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 71. This study's planned 66 months is above that.
Counting every sponsor, half of 70 studies reached it within 56 months; a quarter within 35 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Iron
Weill Medical College of Cornell University →