Daily Iron vs Every-other-day Iron for Pediatric Patients With IDA
- 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
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iron every other day iron sulfate Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every other day. Iron every day iron sulfate Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every day.
- Primary Outcome Measures
Name Time Method Hemoglobin stabilization 3 months standard per age
Serum ferritin stabilization 3 months standard per age
- Secondary Outcome Measures
Name Time Method Hepcidin level 3 months observation of hepcidin levels under clinic conditions