Clinical trial NCT06550362: Daily Iron vs Every-other-day Iron for Pediatric Patients With IDA
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Iron Deficiency Anemia
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Hemoglobin stabilization
timeFrame: Change between baseline and 3 months post-enrollment
measure: Serum Ferritin stabilization
timeFrame: Change between baseline and 3 months post-enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda Univeristy
name: Albert Kheradpour, MD
role: PRINCIPAL_INVESTIGATOR
References: