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

NCT06550362 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 5240248
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Iron every other day

EXPERIMENTAL

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

Drug: iron sulfate

Iron every day

ACTIVE COMPARATOR

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

Drug: iron sulfate

Interventions

iron sulfate DRUG

Oral iron administration

Iron every day; Iron every other day

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Albert Kheradpour, MD

  Loma Linda Univeristy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Kheradpour, MD

CONTACT

909.651.1910; akheradp@llu.edu

Noela Ndrekaj, PharmD

CONTACT

909.651.1926

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share