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NCT04371536 · ClinicalTrials.gov registry record · Phase 3
Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD)
A Phase 3 study of Iron Deficiency Anemia and Iron-deficiency, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
- 1
- Study location
NCT04371536 is a Phase 3 study of Iron Deficiency Anemia and Iron-deficiency that has completed, run by Baylor College of Medicine. The registered enrollment target is 1 participants, below the 194-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04371536, a Phase 3 study of Iron Deficiency Anemia and Iron-deficiency, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
- 1
- Study location
Study Summary
Iron deficiency anemia (IDA) affects nearly half a million young children in the United States. Most children take liquid iron medicine by mouth for at least 3 months. However, some children take longer to get better with this medicine. This study is trying to compare different ways of giving iron medicine to young children. For young children in the US, the main cause of IDA is nutritional, or not having enough iron in the foods they eat. This often happens when kids drink too much cow milk and/or not eating enough foods that have a lot of iron. Iron deficiency is most common in children ages 1 to 4 years of age, during a time that is important for brain development. More severe and long-lasting IDA is associated with worse brain development outcomes. That is why researchers want to understand the fastest way for kids with IDA to get better. Standard treatment is oral iron medicine for 3 to 6 months. Many children do not take their iron medicine the full amount of time needed because of side effects like abdominal discomfort, nausea, constipation, and bad taste. Different factors can contribute to patients not completing their IDA therapy. Many families do not understand how important it is to treat IDA or do not have the motivation to continue the medication. This study will offer different methods for treating IDA, including a different method to taking the oral iron therapy. This new method gives oral iron by increasing a family's understanding and motivation. Another research study that interviewed families of young children with IDA found ways that helped the patients to continue their therapy. Using that information, a website called IRONCHILD was created to help motivate parents to get their children to continue the oral iron medicine. Research studies that compare these different IDA treatment methods in young children are needed and could have benefits to short-term clinical and long-term brain development. However, we do not know whether families of
Conditions Studied
Interventions
- DRUG Ferrous Sulfate
- BEHAVIORAL IRONCHILD
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-07-09 |
| Est. Completion | 2022-03-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04371536
The ClinicalTrials.gov registry entry for NCT04371536 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 194-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (99% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Iron Deficiency Anemia appearing as the primary indexed condition, and to 2 interventions - of which Ferrous Sulfate is the first listed.
NCT04371536 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04371536 about?
NCT04371536 is a clinical study titled "Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD)". Iron deficiency anemia (IDA) affects nearly half a million young children in the United States. Most children take liquid iron medicine by mouth for at least 3 months. However, some children take longer to get better with this medicine. This study is trying to compare different ways of giving iron m...
What is the current status of trial NCT04371536?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2021-07-09. Estimated completion is 2022-03-09.
What conditions does trial NCT04371536 study?
This clinical trial studies the following conditions: Iron Deficiency Anemia, Iron-deficiency.
What interventions are being tested in trial NCT04371536?
The interventions under investigation include: Ferrous Sulfate (DRUG), IRONCHILD (BEHAVIORAL).
Who is sponsoring clinical trial NCT04371536?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04371536 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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