Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD)

Iron Deficiency Anemia Clinical Trial

Official title: A Single-Center, Open-Label, Randomized Feasibility Trial of Standard Oral Iron Therapy Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children With Nutritional Iron Deficiency Anemia

Status Completed

Clinical Trial 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.

Clinical Trial Description

First, the doctor will confirm that patients are eligible for the study. Patients will complete the following procedures:

• Medical history including prior hospitalizations, lab results, medications, diet, social and family history

• Comprehensive Physical Examination which includes measurement of vital signs, examination of the head, eyes, ears, nose, mouth, heart, lungs, abdomen, and skin.

• Blood samples: Patients will not have any extra blood draws for this study, as the investigators will draw the blood during routine blood draws. Investigators will ask to take a little extra blood (less than half a teaspoon) for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes.

Patients will be on the study for 12 weeks. Patients will receive dietary counseling on the amount of cow milk they may have and information sheets on iron-rich foods.

There are 2 different treatments in this study and patients cannot choose which treatment they receive. Instead, they will be randomly assigned to one of the two treatments. That means there is a 50-50 chance that patients will receive liquid iron medicine by itself or that patients will receive liquid iron medicine with access to the website.

Depending on which method of care patients are assigned to, they will complete the following procedures below.

1. Oral Iron Therapy:

Patients will receive liquid iron medicine by mouth once per day for 12 weeks. Patients will first receive this medicine during their first visit.

During the Week 4 visit, patients will compete the following procedures:

• Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes

• Focused Physical Exam which includes measurement of vital signs, examination of the eyes, mouth, heart, lungs, abdomen, and skin.

• Patients will be asked of any side effects that they may be having.

During the Week 8 visit, patients will return to the clinic only to pick up the oral iron medicine.

During the Week 12 visit, patients will complete the following procedures:

• Medical history including prior hospitalizations, lab results, medications, diet, social and family history

• Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests.

• Focused Physical Exam which includes measurement of vital signs, examination of the abdomen and skin.

• Patients will be asked of any side effects that they may be having.

2. Oral Iron Therapy and IRONCHILD:

Patients will receive liquid iron medicine by mouth once per day for 12 weeks. Patients will receive this medication during their first visit. Patients will also be given access to a website called IRONCHILD. Patients will be shown the website, including videos, at each in-clinic visit (Baseline, Week 4, and Week 12). This website was created for patients and their parent/guardian to help patients learn more about the importance of taking their oral iron therapy.

The study team will show patients how to use the website. Patients will be given a unique log-in and password with instructions on how to access the site between visits. There are 3 sessions (one per clinic visit). One session will be completed per visit, and each session should be about 15 minutes or less. Patients will also be able to access this website from home.

During the Week 4 visit, patients will compete the following procedures:

• Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes.

• Focused Physical Exam which includes measurement of vital signs, examination of the eyes, mouth, heart, lungs, abdomen, and skin.

• Patients will be asked of any side effects that they may be having.

During the Week 8 Visit, patients will return to the clinic only to pick up their oral iron medicine.

During the Week 12 visit, patients will complete the following procedures:

• Medical history including prior hospitalizations, lab results, medications, diet, social and family history

• Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes

• Focused Physical Exam which includes measurement of vital signs, examination of the abdomen and skin.

• Patients will be asked of any side effects that they may be having. ;

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia
• Iron-deficiency

• NCT number: NCT04371536
• Study type: Interventional
• Source: Baylor College of Medicine
• Status: Completed
• Phase: Phase 3
• Start date: July 9, 2021
• Completion date: March 9, 2022