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

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.

Conditions

• Iron Deficiency Anemia
• Iron-deficiency

Interventions

DRUG

Ferrous Sulfate

Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.

BEHAVIORAL

IRONCHILD

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Jacquelyn M Powers, MD · Baylor College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

48 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-09

Primary Completion

2022-02-01

Completion

2022-03-09

FDA Drug

Yes

Countries

• United States

Study Locations