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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Drug: iron sulfate

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Albert Kheradpour, MD; Phone Number: 909.651.1910; Email: akheradp@llu.edu
• Study Contact Backup: Name: Noela Ndrekaj, PharmD; Phone Number: 909.651.1926

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron every other day; Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every other day.	Drug: iron sulfate; Oral iron administration
Active Comparator: Iron every day; Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every day.	Drug: iron sulfate; Oral iron administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin stabilization	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.	Change between baseline and 3 months post-enrollment
Serum Ferritin stabilization	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.	Change between baseline and 3 months post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepcidin level	observation of hepcidin levels under clinic conditions	3 months

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Albert Kheradpour, MD, Loma Linda Univeristy

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Anemia, Iron-Deficiency; Organic Chemicals; Carbohydrates; Coordination Complexes; Polysaccharides; Glucans; Dextrans; Iron-Dextran Complex
• Other Study ID Numbers: 5240248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD with other researchers. Only study results will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes