Status:
COMPLETED
Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Iron Deficiency Anemia
Iron-deficiency
Eligibility:
All Genders
12-48 years
Phase:
PHASE3
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 long...
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,...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
July 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04371536
Start Date
July 9 2021
End Date
March 9 2022
Last Update
May 6 2023
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030