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

3 november 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

150

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • New York, New York, Förenta staterna, 10065
        • Rekrytering
        • Weill Cornell Medicine
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

3 år till 21 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / 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
Läkemedel: Iron (ferrous sulfate)

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

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

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Median Hemoglobin Level
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of Participants in Clinical Remission According to the Pediatric Crohn's Disease Activity Index (PCDAI)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Weill Medical College of Cornell University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

13 september 2023

Primärt slutförande (Beräknad)

13 mars 2029

Avslutad studie (Beräknad)

30 juni 2029

Studieregistreringsdatum

Först inskickad

3 november 2026

Först inskickad som uppfyllde QC-kriterierna

3 november 2026

Första postat (Faktisk)

9 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 22-07024996

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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