Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550362
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Daily Iron vs Every-other-day Iron for Pediatric Patients With IDA
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None