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

NCT04371536 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: H-45869 IRONCHILDK23HL132001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia; Iron-deficiency

Keywords

Iron Deficiency Anemia; Nutritional iron deficiency; Ferrous sulfate oral liquid formulation

Outcome Measures

Primary Outcomes (2)

• Percentage of Eligible Patients Enrolled

  We hypothesized that 50% or more of eligible patients would enroll the study.

  Baseline

• Percentage of Enrolled Subjects Who Agree With Randomization

  We hypothesized that randomization would be feasible, defined as agreement with randomization in greater than or equal to 80% of enrolled subjects per arm.

  Baseline

Study Arms (2)

Arm A: Oral iron therapy

ACTIVE COMPARATOR

Arm A is standard oral iron therapy for 3 months.

Drug: Ferrous Sulfate

Arm B: Oral iron therapy plus IRONCHILD web-based intervention

EXPERIMENTAL

Oral iron therapy as per Arm A plus the IRONCHILD web-based intervention aimed at promoting oral iron adherence. This web-based intervention was developed specifically for caregivers of young children with nutritional iron deficiency anemia to promote oral iron adherence.

Drug: Ferrous Sulfate; Behavioral: IRONCHILD

Interventions

Ferrous Sulfate DRUG

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

Also known as: Feosol, Fer-Iron

Arm A: Oral iron therapy; Arm B: Oral iron therapy plus IRONCHILD web-based intervention

IRONCHILD BEHAVIORAL

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

Also known as: Web-based intervention

Arm B: Oral iron therapy plus IRONCHILD web-based intervention

Eligibility Criteria

• Age: 12 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age greater than or equal to 12 months to less than 48 months
• 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.
• 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
• Primary language of English or Spanish
• Access to smartphone with data plan and/or other internet access (i.e. home computer)

You may not qualify if:

• Iron deficiency likely or definitely due to blood loss from the intestine or other sites.
• Administration of a blood transfusion
• History or evidence of intestinal malabsorption
• History of prior intravenous iron therapy
• Major co-morbidity such as a serious chronic medical condition unrelated to iron deficiency apparent on history, physical examination, or laboratory tests
• Other cause of anemia (sickle cell disease, thalassemia, bone marrow failure, etc.) apparent by history, physical examination, and/or laboratory tests.
• Inability to tolerate oral medications
• Other medical or social factors at discretion of treating physician

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous sulfate; Iron-Dextran Complex; FIT1 protein, Arabidopsis

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Jacquelyn Powers
• Organization: Baylor College of Medicine

jmpowers@txch.org

832-824-7330

Study Officials

• Jacquelyn M Powers, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: July 9, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 9, 2022
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-04

Locations

US (1)