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
Intervention: Ferrous Sulfate; IRONCHILD
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 12 Months
Maximum age: 48 Months
Healthy volunteers: No
Keywords: Iron Deficiency Anemia; Nutritional iron deficiency; Ferrous sulfate oral liquid formulation

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age greater than or equal to 12 months to less than 48 months

          2. Iron deficiency anemia (IDA) confirmed by hematologic indices and iron laboratory
             parameters*

               -  Hgb between greater than or equal to 6 g/dL AND less than or equal to 10 g/dL

               -  MCV less than or equal to 70 fl

               -  Ferritin less than or equal to 15 ng/mL OR TIBC greater than or equal to 425
                  microgram/dL *CBC indices must be performed with 7 days of study enrollment. Iron
                  indices must be performed within 30 days of study enrollment.

          3. Clinical history consistent with nutritional IDA such as prolonged breastfeeding
             without adequate iron supplementation or excessive milk intake (cow milk, almond milk,
             soy milk, goat milk or other milk, excluding breastmilk), defined as greater than or
             equal to 3 cups (24 ounces)per day

          4. Primary language of English or Spanish

          5. Access to smartphone with data plan and/or other internet access (i.e. home computer)

        Exclusion Criteria:

          1. Iron deficiency likely or definitely due to blood loss from the intestine or other
             sites.

          2. Administration of a blood transfusion

          3. History or evidence of intestinal malabsorption

          4. History of prior intravenous iron therapy

          5. Major co-morbidity such as a serious chronic medical condition unrelated to iron
             deficiency apparent on history, physical examination, or laboratory tests

          6. Other cause of anemia (sickle cell disease, thalassemia, bone marrow failure, etc.)
             apparent by history, physical examination, and/or laboratory tests.

          7. Inability to tolerate oral medications

          8. Other medical or social factors at discretion of treating physician