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

Summary

Participation Requirements

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...

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. 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. 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.

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