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

Phase 4

Not yet recruiting

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: iron sulfate

• 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.

Study Timeline

• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-09
• Study First Posted: 2024-08-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-03-25
• Study Start: 2025-05
• Primary Completion: 2026-05
• Study Completion: 2026-05

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).

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

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	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.