Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD)
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
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 young children with IDA will be willing to
participate in this type of study that has different treatment methods (oral iron therapy and
oral iron therapy with a web-based adherence intervention).
The goal of this clinical research study is to learn which of the two methods of care will be
the best way for children with iron deficiency anemia to receive therapy.