Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD)
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| ClinicalTrials.gov Identifier: NCT04371536 |
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Recruitment Status :
Completed
First Posted : May 1, 2020
Results First Posted : May 6, 2023
Last Update Posted : May 6, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Iron Deficiency Anemia Iron-deficiency | Drug: Ferrous Sulfate Behavioral: IRONCHILD | Phase 3 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | July 9, 2021 |
| Actual Primary Completion Date : | February 1, 2022 |
| Actual Study Completion Date : | March 9, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm A: Oral iron therapy
Arm A is standard oral iron therapy for 3 months.
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Drug: Ferrous Sulfate
Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
Other Names:
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Experimental: Arm B: Oral iron therapy plus IRONCHILD web-based intervention
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.
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Drug: Ferrous Sulfate
Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
Other Names:
Behavioral: IRONCHILD Delivery of the intervention at each visit should take 15 minutes or less.
Other Name: Web-based intervention |
- Percentage of Eligible Patients Enrolled [ Time Frame: Baseline ]We hypothesized that 50% or more of eligible patients would enroll the study.
- Percentage of Enrolled Subjects Who Agree With Randomization [ Time Frame: Baseline ]We hypothesized that randomization would be feasible, defined as agreement with randomization in greater than or equal to 80% of enrolled subjects per arm.
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| Ages Eligible for Study: | 12 Months to 48 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age greater than or equal to 12 months to less than 48 months
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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)
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371536
| United States, Texas | |
| Texas Children's Hospital | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Jacquelyn M Powers, MD | Baylor College of Medicine |
Documents provided by Jacquelyn Powers, MD, MS, Baylor College of Medicine:
| Responsible Party: | Jacquelyn Powers, MD, MS, Assistant Professor, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT04371536 |
| Other Study ID Numbers: |
H-45869 IRONCHILD K23HL132001 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 1, 2020 Key Record Dates |
| Results First Posted: | May 6, 2023 |
| Last Update Posted: | May 6, 2023 |
| Last Verified: | April 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Iron Deficiency Anemia Nutritional iron deficiency Ferrous sulfate oral liquid formulation |
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Anemia Anemia, Iron-Deficiency Iron Deficiencies Deficiency Diseases Hematologic Diseases |
Iron Metabolism Disorders Metabolic Diseases Anemia, Hypochromic Malnutrition Nutrition Disorders |