Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371536
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : September 2, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jacquelyn Powers, MD, MS, Baylor College of Medicine

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.


Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Iron-deficiency Drug: Ferrous Sulfate Behavioral: IRONCHILD Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Active Comparator: Arm A: Oral iron therapy
Arm A is standard oral iron therapy for 3 months.
Drug: Ferrous Sulfate
Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
Other Names:
  • Feosol
  • Fer-Iron

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.
Drug: Ferrous Sulfate
Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
Other Names:
  • Feosol
  • Fer-Iron

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
Other Name: Web-based intervention




Primary Outcome Measures :
  1. Percentage of eligible patients enrolled [ Time Frame: 12 weeks ]
    Enrollment will be feasible (i.e. greater than or equal to 50% enrollment of eligible patients)

  2. Percentage of enrolled subjects who agree with randomization [ Time Frame: 12 weeks ]
    Randomization will be feasible (i.e. greater than or equal to 80% agreement of enrolled subjects with randomization per Arm)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Jacquelyn M Powers, MD (832) 824-7330 jmpowers@texaschildrens.org

Locations
Layout table for location information
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Jacquelyn M Powers, MD    832-824-7330    jmpowers@texaschildrens.org   
Sponsors and Collaborators
Baylor College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Jacquelyn M Powers, MD Baylor College of Medicine
Layout table for additonal information
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
Last Update Posted: September 2, 2021
Last Verified: September 2021

Layout table for additional information
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
Keywords provided by Jacquelyn Powers, MD, MS, Baylor College of Medicine:
Iron Deficiency Anemia
Nutritional iron deficiency
Ferrous sulfate oral liquid formulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders