Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06550362 | NOT YET RECRUITING | Iron Deficiency Anemia

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

Loma Linda University

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.

Condition or disease

Iron Deficiency Anemia

Intervention/treatment

iron sulfate

Phase

PHASE4

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
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official 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.
Actual Study Start Date : 2025-05
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2026-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Year to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Daily Iron vs Every-other-day Iron for Pediatric Patients With IDA

Location Details

NCT06550362

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found