Daily Iron vs Every-other-day Iron for Pediatric Patients With IDA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iron sulfate.
- Who it may be relevant to
- Registry conditions: Iron Deficiency Anemia. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Controlled Trial Comparing Daily Oral Iron Administration to Every Alternate Day Iron Administration in the Treatment of Iron Deficiency Anemia in Pediatric Patients.
Overview
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
- Drug iron sulfate
Oral iron administration
Primary outcome measures
- Hemoglobin stabilization [Time frame: Change between baseline and 3 months post-enrollment]
- Serum Ferritin stabilization [Time frame: Change between baseline and 3 months post-enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06550362 · 5240248