NCT07391371

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Medicine, Mandalay · Academic / Other
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Alternate-day oral Iron (III)-hydroxide polymaltose complex	The intervention uses the same oral Iron (III)-hydroxide polymaltose complex in both study arms, differing only in dosing frequency (alternate-day versus daily administration)
DRUG	Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing	This intervention uses oral Iron (III)-hydroxide polymaltose complex, a non-ionic ferric iron preparation, administered as a liquid formulation with dosing based on body weight. This study evaluates the same iron preparation in both study arms, with the dosing frequency (daily versus alternate-day administration) as the only variable. This approach allows assessment of the impact of dosing schedule on haemoglobin response, gastrointestinal tolerability, and treatment adherence in children with iron deficiency anaemia, while minimizing confounding from formulation-related differences.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-10-30
• Completion: 2027-01-31
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

2 sites across 1 country: Burma