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NCT Number: NCT06550362

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iron sulfate

Drug

Oral iron administration

Primary outcomes

  1. Hemoglobin stabilization

    Time frame: 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.

  2. Serum Ferritin stabilization

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Albert Kheradpour, MD

CONTACT

[email protected]

909.651.1910

Noela Ndrekaj, PharmD

CONTACT

909.651.1926

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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