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

Loma Linda University (LLU)

Status and phase: Begins enrollment in 2 months; Phase 4

Conditions: Iron Deficiency Anemia

Treatments: Drug: iron sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT06550362

5240248

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Iron every other day

Experimental group

Description:

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

Treatment:

Drug: iron sulfate

Iron every day

Active Comparator group

Description:

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

Treatment:

Drug: iron sulfate