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Daily Iron vs Every-other-day Iron for Pediatric Patients With IDA

Phase 4
Not yet recruiting
Conditions
Iron Deficiency Anemia
Interventions
Registration Number
NCT06550362
Lead Sponsor
Loma Linda University
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
100
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).
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Iron every other dayiron sulfateOral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every other day.
Iron every dayiron sulfateOral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every day.
Primary Outcome Measures
NameTimeMethod
Hemoglobin stabilization3 months

standard per age

Serum ferritin stabilization3 months

standard per age

Secondary Outcome Measures
NameTimeMethod
Hepcidin level3 months

observation of hepcidin levels under clinic conditions

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