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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: 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
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zayar Kyaw Win, MBBS, MMed Sc (Paediatrics); Phone Number: +9595123141; Email: dr.zayar.k.w@gmail.com

Study Locations

• Burma
  • Mandalay Region
    • Mandalay, Mandalay Region, Burma
      • Paediatrics ward, 300 Beeded Teaching Hospital, Mandalay
      • Contact: Kyaw Myo, Professor of Paediatrics; Phone Number: +959798599253; Email: kyawmyo@ummedu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alternate-day group; Alternate-day group receiving oral iron III polymaltose complex 3mg/kg/day	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.
Experimental: Daily group; Daily group receiving oral iron III polymaltose complex 3mg/kg/day	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study alternate-day versus daily oral iron therapy in children with iron deficiency anaemia	To compare the difference in mean haemoglobin concentration, mean serum ferritin level after 12 weeks of oral iron therapy between alternate-day and daily oral iron therapy in children with iron deficiency anaemia	1 year duration

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare the difference in mean haemoglobin concentration, mean serum ferritin level after 12 weeks of oral iron therapy between alternate-day and daily oral iron therapy in children with iron deficiency anaemia	one year duration

Collaborators and Investigators

• Sponsor: University of Medicine, Mandalay

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Anemia, Iron-Deficiency; Inorganic Chemicals; Elements; Metals; Metals, Heavy; Transition Elements; Iron
• Other Study ID Numbers: UMM-13(1/2025)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No