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.
| Registry | NCT06550362 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | Loma Linda University (Other) |
| Conditions | Iron Deficiency Anemia |
| Interventions | iron sulfate (Drug) |
| Dates | start 2026-12-01 (estimated), primary completion 2027-05-01 (estimated), completion 2027-05-01 (estimated), first posted 2024-08-13, last updated 2026-07-10 |
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All trials for Iron Deficiency Anemia All trials of iron sulfate
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Iron every other day | Experimental | Drug: iron sulfate | Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every other day. |
| Iron every day | Active comparator | Drug: iron sulfate | Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every day. |
Sex: All, ages: 1 Year to 18 Years
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