Trial Outcomes & Findings for Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD) (NCT NCT04371536)
NCT ID: NCT04371536
Last Updated: 2023-05-06
Results Overview
We hypothesized that 50% or more of eligible patients would enroll the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1 participants
Primary outcome timeframe
Baseline
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
Arm A: Oral Iron Therapy
Arm A is standard oral iron therapy for 3 months.
Ferrous Sulfate: Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
|
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.
Ferrous Sulfate: Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
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
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Iron Versus Oral Iron Plus a Web-based Behavioral Intervention in Young Children (IRONCHILD)
Baseline characteristics by cohort
| Measure |
Arm A: Oral Iron Therapy
n=1 Participants
Arm A is standard oral iron therapy for 3 months.
Ferrous Sulfate: Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
|
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.
Ferrous Sulfate: Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
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
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2 Years
n=5 Participants
|
—
|
2 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Hemoglobin
|
7.3 g/dL
n=5 Participants
|
—
|
7.3 g/dL
n=5 Participants
|
|
Ferritin
|
5 ng/mL
n=5 Participants
|
—
|
5 ng/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: No enrolled subjects were randomized to Arm B.
We hypothesized that 50% or more of eligible patients would enroll the study.
Outcome measures
| Measure |
Arm A: Oral Iron Therapy
n=1 Participants
Arm A is standard oral iron therapy for 3 months.
Ferrous Sulfate: Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
|
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.
Ferrous Sulfate: Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
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
|
|---|---|---|
|
Percentage of Eligible Patients Enrolled
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: No enrolled subjects were randomized to Arm B.
We hypothesized that randomization would be feasible, defined as agreement with randomization in greater than or equal to 80% of enrolled subjects per arm.
Outcome measures
| Measure |
Arm A: Oral Iron Therapy
n=1 Participants
Arm A is standard oral iron therapy for 3 months.
Ferrous Sulfate: Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
|
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.
Ferrous Sulfate: Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
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
|
|---|---|---|
|
Percentage of Enrolled Subjects Who Agree With Randomization
|
1 Participants
|
0 Participants
|
Adverse Events
Arm A: Oral Iron Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm B: Oral Iron Therapy Plus IRONCHILD Web-based Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: Oral Iron Therapy
n=1 participants at risk
Arm A is standard oral iron therapy for 3 months.
Ferrous Sulfate: Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
|
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.
Ferrous Sulfate: Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
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
|
|---|---|---|
|
Gastrointestinal disorders
Emesis, Constipation
|
100.0%
1/1 • Number of events 1 • Twelve week study period
Adverse events were assessed in all enrolled subjects at all research visits.
|
—
0/0 • Twelve week study period
Adverse events were assessed in all enrolled subjects at all research visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place