Clinical trial NCT04371536: Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Iron-deficiency
Keywords: Iron Deficiency Anemia
Nutritional iron deficiency
Ferrous sulfate oral liquid formulation
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-05-01
Enrollment: 1
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Percentage of Eligible Patients Enrolled
timeFrame: Baseline
measure: Percentage of Enrolled Subjects Who Agree With Randomization
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Jacquelyn M Powers, MD
role: PRINCIPAL_INVESTIGATOR
References: