Iron Deficiency Anemia
Conditions
Brief summary
Iron Deficiency Anemia (IDA) is a prevalent global health issue affecting a significant proportion of the population, including children. While daily oral iron supplementation is a common approach to treat IDA, concerns regarding side effects and compliance have led to exploration of alternative dosing schedules, such as every-other-day. This study aims to investigate the efficacy and safety of daily versus every other day oral iron supplementation in the management of IDA in pediatric patients.
Detailed description
This is a prospective open-label randomized controlled study. Patients will be randomized into two groups, one group (investigational) will receive oral iron every other day (every 48 hours) and the control group will be prescribed daily oral iron. Data will be collected prospectively including compliance assessment, side effect profile, hemoglobin (CBC), iron stores, hepcidin levels and other monitoring as relevant for best patient care. At the time of enrollment and following randomization patients will commence treatment with oral iron. Duration of treatment will be 3 months. Laboratory monitoring will also commence at the time of enrollment along with ongoing evaluation of signs and symptoms of anemia, side effects of oral iron therapy, compliance with oral iron therapy. Duration of monitoring will be 6 months. A medication diary will be provided to all subjects of each group to track their intake of their oral iron supplementation.
Interventions
DRUGiron sulfate
Oral iron administration
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed Iron Deficiency Anemia * Pediatric patients (1-18 years of age) without regard of gender, race, ethnicity nor language. * Able and willing to take oral iron (tablet or liquid).
Exclusion criteria
* Pregnant or lactating patients * Known allergies or intolerance to oral iron formulations * Concomitant chronic medical conditions affecting iron metabolism * Short gut syndrome * Celiac disease * Inflammatory bowel disease * Cancer * Chronic kidney disease * Blood transfusions in the past 3 months * IV iron administration in the past 3 months * Oral iron supplementation in the past 2 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin stabilization | Change between baseline and 3 months post-enrollment | Hemoglobin status will be assessed per blood draw at baseline and again at 3 months post-enrollment. Subject will be considered stabilized if hemoglobin levels are within normal range for subject age or demonstrate significant improvement since baseline during that timeframe. |
| Serum Ferritin stabilization | Change between baseline and 3 months post-enrollment | Serum Ferritin status will be assessed per blood draw at baseline and again at 3 months post-enrollment. Subject will be considered stabilized if Serum Ferritin levels are within normal range for subject age or demonstrate significant improvement since baseline during that timeframe. |
Contacts
CONTACTAlbert Kheradpour, MD
CONTACTNoela Ndrekaj, PharmD
PRINCIPAL_INVESTIGATORAlbert Kheradpour, MD
Loma Linda Univeristy
Outcome results
None listed