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Iron Treatment for Iron Deficiency Anemia in Children and Young Adults With Crohn's Disease

3. november 2026 oppdatert av: Weill Medical College of Cornell University

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • New York, New York, Forente stater, 10065
        • Rekruttering
        • Weill Cornell Medicine
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

3 år til 21 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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
Legemiddel: Iron (ferrous sulfate)

Iron supplementation for treatment of iron deficiency anemia. The dose, schedule, and route are determined by the assigned study arm.
Eksperimentell: Low-Dose-Every-Other-Day Oral Iron

Participants randomized to this arm receive oral iron at 1-2 mg/kg every other day
Legemiddel: Iron (ferrous sulfate)

Iron supplementation for treatment of iron deficiency anemia. The dose, schedule, and route are determined by the assigned study arm.
Aktiv komparator: 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.
Legemiddel: Iron (ferrous sulfate)

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Median Hemoglobin Level
Tidsramme: At routine follow-up visits typically every 4 to 12 weeks, for up to 3 years after enrollment.

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)
Tidsramme: At routine follow-up visits, typically every 4-12 weeks, for up to 3 years after enrollment.

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
Tidsramme: Approximately every 6 months during follow-up, for up to 3 years after enrollment.

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
Tidsramme: Approximately every 6 months during follow-up, for up to 3 years after enrollment.

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
Tidsramme: Approximately every 6 months during follow-up for up to 3 years.

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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants in Clinical Remission According to the Pediatric Crohn's Disease Activity Index (PCDAI)
Tidsramme: At routine follow-up visits, typically every 4 to 12 weeks, for up to 3 years after enrollment.

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
Tidsramme: At routine follow-up visits, typically every 4 to 12 weeks, for up to 3 years after enrollment

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
Tidsramme: From enrollment through up to 3 years

Number of participants with fatigue documented as an adverse event during study follow-up.
From enrollment through up to 3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Weill Medical College of Cornell University

Etterforskere

  • Hovedetterforsker: Robbyn E Sockolow, MD, Weill Medical College of Cornell University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. september 2023

Primær fullføring (Antatt)

13. mars 2029

Studiet fullført (Antatt)

30. juni 2029

Datoer for studieregistrering

Først innsendt

3. november 2026

Først innsendt som oppfylte QC-kriteriene

3. november 2026

Først lagt ut (Faktiske)

9. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 22-07024996

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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