Iron Treatment for Iron Deficiency Anemia in Children and Young Adults With Crohn's Disease
NCT07925450, Phase 4, Recruiting, Weill Medical College of Cornell University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Iron Treatment for Iron Deficiency Anemia in Children and Young Adults With Crohn's Disease | ClinicalTrials.gov |
| NCT number | NCT07925450 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Weill Medical College of Cornell University | ClinicalTrials.gov |
| Conditions | Crohn's Disease, Iron Deficiency Anemia | ClinicalTrials.gov |
| Interventions | Iron (ferrous sulfate) | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Median Hemoglobin Level | 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. | ClinicalTrials.gov |
| Primary | Median MCV (Mean Corpuscular Volume) | 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. | ClinicalTrials.gov |
| Primary | Median Serum Iron Level | 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. | ClinicalTrials.gov |
| Primary | Median Iron Saturation | 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. | ClinicalTrials.gov |
| Primary | Median Ferritin Level | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants in Clinical Remission According to the Pediatric Crohn's Disease Activity Index (PCDAI) | 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. | ClinicalTrials.gov |
| Secondary | General Wellbeing Score | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants with Fatigue | From enrollment through up to 3 years | Number of participants with fatigue documented as an adverse event during study follow-up. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)