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

NCT ID: NCT06550362

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-31
• Study Completion Date: 2027-05-31

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.

Conditions

Iron Deficiency Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iron every other day

Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every other day.

Group Type: EXPERIMENTAL

iron sulfate

Intervention Type: DRUG

Oral iron administration

Iron every day

Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every day.

Group Type: ACTIVE_COMPARATOR

iron sulfate

Intervention Type: DRUG

Oral iron administration

Interventions

iron sulfate

Oral iron administration

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert Kheradpour, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda Univeristy

Central Contacts

Noela Ndrekaj, PharmD

Role: CONTACT

909.651.1926

Albert Kheradpour, MD

Role: CONTACT

akheradp@llu.edu

909.651.1910

Other Identifiers

5240248

Identifier Type: -

Identifier Source: org_study_id