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

ConditionIron Deficiency Anemia

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age1-18

SponsorLoma Linda University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Pregnant or lactating patients

Known allergies or intolerance to oral iron formulations

Concomitant chronic medical conditions affecting iron metabolism

Short gut syndrome

Trial design

Design model

Parallel

Treatments tested in this trial

iron sulfate
Drug
Oral iron administration

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Iron every other dayExperimental treatment 1 intervention

Group B: Iron every dayActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

Change between baseline and 3 months post-enrollment

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loma Linda University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: