Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD)
Condition: Iron Deficiency Anemia; Iron-deficiency
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): Ferrous Sulfate; IRONCHILD
Intervention type(s): Drug; Behavioral
Intervention description(s): Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.; Delivery of the intervention at each visit should take 15 minutes or less.
Baseline visit (Session 1) content will be viewed
At 1-month follow-up visit, additional (Session 2) content will be viewed
At 3-month final visit, patients will view final (Session 3) content
Other intervention name(s): Feosol; Fer-Iron; Web-based intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iron Deficiency Anemia; Nutritional iron deficiency; Ferrous sulfate oral liquid formulation