Clinical trial

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.

Aliases
5240248, NCT06550362
Name
5240248
Description
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.
Trial arms
Trial start
2024-09-01
Estimated PCD
2024-11-01
Trial end
2025-02-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
iron sulfate
Oral iron administration
Arms:
Iron every day, Iron every other day
Size
100
Primary endpoint
Hemoglobin stabilization
3 months
Serum ferritin stabilization
3 months
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-08-13

1 organization

1 product

2 indications