Alternate-day Versus Daily Oral Iron Therapy in Children With Iron Deficiency Anaemia

University of Medicine, Mandalay

Status and phase: Not yet enrolling; Phase 4

Conditions: Iron Deficiency Anemia

Treatments: Drug: Alternate-day oral Iron (III)-hydroxide polymaltose complex; Drug: Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing

Study type: Interventional

Funder types: Other

Identifiers

NCT07391371

UMM-13(1/2025)

Details and patient eligibility

About

The goal of this clinical trial is to find out whether Iron (III)-hydroxide polymaltose complex (IPC) given on an alternate-day schedule works as well as daily dosing in treating iron deficiency anaemia in children. The study will also look at the safety and tolerability of IPC.

The main questions this study aims to answer are:

Does alternate-day oral IPC improve haemoglobin levels and serum ferritin level as effectively as daily oral IPC?

Does alternate-day dosing reduce gastrointestinal side effects compared to daily dosing?

Does alternate-day dosing improve treatment adherence in children?

Researchers will compare alternate-day IPC with daily IPC to determine the most effective and well-tolerated dosing schedule for children with iron deficiency anaemia.

Participants will:

Receive oral Iron (III)-hydroxide polymaltose complex either daily or on alternate days for 12 weeks treatment period

Attend regular clinic visits for clinical assessment and blood investigations

Be monitored for adverse effects, adherence to treatment, and improvement in haemoglobin and serum ferritin levels

Enrollment: 60 estimated patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria Six months to 12 years old children with iron deficiency anaemia

Exclusion criteria

1. Critically ill child
2. Children with documented chronic illnesses (e.g., known renal failure, known liver disease)
3. Children with known cases of thalassemia
4. Children with severe anaemia requiring transfusion
5. Children who received blood transfusion within the preceding 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Alternate-day group

Experimental group

Description:

Alternate-day group receiving oral iron III polymaltose complex 3mg/kg/day

Treatment:

Drug: Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing

Drug: Alternate-day oral Iron (III)-hydroxide polymaltose complex

Daily group

Experimental group

Description:

Daily group receiving oral iron III polymaltose complex 3mg/kg/day

Treatment:

Drug: Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing

Drug: Alternate-day oral Iron (III)-hydroxide polymaltose complex