Iron Deficiency AnemiaPhase 3NCT04371536
Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD)
A Phase 3 study testing Ferrous Sulfate and IRONCHILD in people with Iron Deficiency Anemia and Iron-deficiency, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 48 months
- Conditions the study is for
- Iron Deficiency Anemia, Iron-deficiency
- What is being tested?
- Ferrous Sulfate and IRONCHILD
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2021to 9 Mar 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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, diet, social and family history
- Comprehensive Physical Examination which includes measurement of vital signs, examination of the head, eyes, ears, nose, mouth, heart, lungs, abdomen, and skin.
- Blood samples: Patients will not have any extra blood draws for this study, as the investigators will draw the blood during routine blood draws. Investigators will ask to take a little extra blood (less than half a teaspoon) for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes.
Patients will be on the study for 12 weeks. Patients will receive dietary counseling on the amount of cow milk they may have and information sheets on iron-rich foods.
There are 2 different treatments in this study and patients cannot choose which treatment they receive. Instead, they will be randomly assigned to one of the two treatments. That means there is a 50-50 chance that patients will receive liquid iron medicine by itself or that patients will receive liquid iron medicine with access to the website.
Depending on which method of care patients are assigned to, they will complete the following procedures below.
- Oral Iron Therapy: Patients will receive liquid iron medicine by mouth once per day for 12 weeks. Patients will first receive this medicine during their first visit. During the Week 4 visit, patients will compete the following procedures:
- Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes
- Focused Physical Exam which includes measurement of vital signs, examination of the eyes, mouth, heart, lungs, abdomen, and skin.
- Patients will be asked of any side effects that they may be having. During the Week 8 visit, patients will return to the clinic only to pick up the oral iron medicine. During the Week 12 visit, patients will complete the following procedures:
- Medical history including prior hospitalizations, lab results, medications, diet, social and family history
- Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests.
- Focused Physical Exam which includes measurement of vital signs, examination of the abdomen and skin.
- Patients will be asked of any side effects that they may be having.
- Oral Iron Therapy and IRONCHILD:
Patients will receive liquid iron medicine by mouth once per day for 12 weeks. Patients will receive this medication during their first visit. Patients will also be given access to a website called IRONCHILD. Patients will be shown the website, including videos, at each in-clinic visit (Baseline, Week 4, and Week 12). This website was created for patients and their parent/guardian to help patients learn more about the importance of taking their oral iron therapy.
The study team will show patients how to use the website. Patients will be given a unique log-in and password with instructions on how to access the site between visits. There are 3 sessions (one per clinic visit). One session will be completed per visit, and each session should be about 15 minutes or less. Patients will also be able to access this website from home.
During the Week 4 visit, patients will compete the following procedures:
- Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes.
- Focused Physical Exam which includes measurement of vital signs, examination of the eyes, mouth, heart, lungs, abdomen, and skin.
- Patients will be asked of any side effects that they may be having.
During the Week 8 Visit, patients will return to the clinic only to pick up their oral iron medicine.
During the Week 12 visit, patients will complete the following procedures:
- Medical history including prior hospitalizations, lab results, medications, diet, social and family history
- Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes
- Focused Physical Exam which includes measurement of vital signs, examination of the abdomen and skin.
- Patients will be asked of any side effects that they may be having.
- Conditions
- Iron Deficiency Anemia, Iron-deficiency
- Being tested
- Ferrous Sulfate, IRONCHILD
- Keywords
- Iron Deficiency Anemia, Nutritional iron deficiency, Ferrous sulfate oral liquid formulation
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous SulfateDrug
Also called Feosol, Fer-Iron
Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
IRONCHILDBehavioural
Also called Web-based intervention
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Oral iron therapy | Active comparator | Arm A is standard oral iron therapy for 3 months. Receives: 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. Receives: Drug: Ferrous Sulfate; Behavioral: IRONCHILD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eligible Patients Enrolled
We hypothesized that 50% or more of eligible patients would enroll the study.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start9 Jul 2021
- Primary completion1 Feb 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jacquelyn Powers, MD, MS, Baylor College of Medicine
- Investigators
- Jacquelyn M Powers, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371536
- Sponsor's protocol ID
- H-45869 IRONCHILD
- Other IDs
- K23HL132001
- Status last verified
- Apr 2023
- First submitted
- 29 Apr 2020
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04371536
- Acronym / sponsor ID
- H-45869 IRONCHILD
- Conditions
- Iron Deficiency Anemia, Iron-deficiency
- Keywords
- Iron Deficiency Anemia, Nutritional iron deficiency, Ferrous sulfate oral liquid formulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, diet, social and family history
- Comprehensive Physical Examination which includes measurement of vital signs, examination of the head, eyes, ears, nose, mouth, heart, lungs, abdomen, and skin.
- Blood samples: Patients will not have any extra blood draws for this study, as the investigators will draw the blood during routine blood draws. Investigators will ask to take a little extra blood (less than half a teaspoon) for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes.
Patients will be on the study for 12 weeks. Patients will receive dietary counseling on the amount of cow milk they may have and information sheets on iron-rich foods.
There are 2 different treatments in this study and patients cannot choose which treatment they receive. Instead, they will be randomly assigned to one of the two treatments. That means there is a 50-50 chance that patients will receive liquid iron medicine by itself or that patients will receive liquid iron medicine with access to the website.
Depending on which method of care patients are assigned to, they will complete the following procedures below.
- Oral Iron Therapy: Patients will receive liquid iron medicine by mouth once per day for 12 weeks. Patients will first receive this medicine during their first visit. During the Week 4 visit, patients will compete the following procedures:
- Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes
- Focused Physical Exam which includes measurement of vital signs, examination of the eyes, mouth, heart, lungs, abdomen, and skin.
- Patients will be asked of any side effects that they may be having. During the Week 8 visit, patients will return to the clinic only to pick up the oral iron medicine. During the Week 12 visit, patients will complete the following procedures:
- Medical history including prior hospitalizations, lab results, medications, diet, social and family history
- Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests.
- Focused Physical Exam which includes measurement of vital signs, examination of the abdomen and skin.
- Patients will be asked of any side effects that they may be having.
- Oral Iron Therapy and IRONCHILD:
Patients will receive liquid iron medicine by mouth once per day for 12 weeks. Patients will receive this medication during their first visit. Patients will also be given access to a website called IRONCHILD. Patients will be shown the website, including videos, at each in-clinic visit (Baseline, Week 4, and Week 12). This website was created for patients and their parent/guardian to help patients learn more about the importance of taking their oral iron therapy.
The study team will show patients how to use the website. Patients will be given a unique log-in and password with instructions on how to access the site between visits. There are 3 sessions (one per clinic visit). One session will be completed per visit, and each session should be about 15 minutes or less. Patients will also be able to access this website from home.
During the Week 4 visit, patients will compete the following procedures:
- Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes.
- Focused Physical Exam which includes measurement of vital signs, examination of the eyes, mouth, heart, lungs, abdomen, and skin.
- Patients will be asked of any side effects that they may be having.
During the Week 8 Visit, patients will return to the clinic only to pick up their oral iron medicine.
During the Week 12 visit, patients will complete the following procedures:
- Medical history including prior hospitalizations, lab results, medications, diet, social and family history
- Blood Samples: Patients will not have any extra blood draws (pokes) for this study as blood for research will be collected during routine blood draws. About less than half a teaspoon of extra blood will be drawn for research tests. All other blood draws that patients have while on study will be for routine care and not for research purposes
- Focused Physical Exam which includes measurement of vital signs, examination of the abdomen and skin.
- Patients will be asked of any side effects that they may be having.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Oral iron therapy | Active comparator | Drug: Ferrous SulfateArm A is standard oral iron therapy for 3 months. |
| Arm B: Oral iron therapy plus IRONCHILD web-based intervention | Experimental | Drug: Ferrous Sulfate, Behavioral: IRONCHILDOral 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. |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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*
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous SulfateAlso: Feosol, Fer-IronPatients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation. | Drug | Arm A: Oral iron therapy, Arm B: Oral iron therapy plus IRONCHILD web-based intervention |
| IRONCHILDAlso: Web-based interventionDelivery 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 | Behavioural | Arm B: Oral iron therapy plus IRONCHILD web-based intervention |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacquelyn M Powers, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferrous Sulfate and IRONCHILD in people with Iron Deficiency Anemia and Iron-deficiency, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eligible Patients Enrolled (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.