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

NCT07391371 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: UMM-13(1/2025)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Alternate-day group

EXPERIMENTAL

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

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

Daily group

EXPERIMENTAL

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

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

Interventions

Alternate-day oral Iron (III)-hydroxide polymaltose complex DRUG

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)

Alternate-day group; Daily group

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

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.

Alternate-day group; Daily group

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

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

Sponsors & Collaborators

• University of Medicine, Mandalay: lead

Study Sites (2)

Paediatrics ward, 300 Beeded Teaching Hospital, Mandalay

Mandalay, Mandalay Region, Burma

Location

Paediatrics ward, 300 Beeded Teaching Hospital, Mandalay

Mandalay, Mandalay Region, Burma

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Iron

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Zayar Kyaw Win, MBBS, MMed Sc (Paediatrics)

CONTACT

+9595123141; dr.zayar.k.w@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant Paediatrician, Department of Paediatrics

Model Details: The study is designed as an interventional, randomized, parallel-group clinical trial. Eligible children ( total 60) with iron deficiency anaemia will be randomly assigned in a 1:1 ratio to one of two intervention groups. One group will receive oral Iron (III)-hydroxide polymaltose complex administered daily, while the other group will receive the same preparation on an alternate-day schedule. Each participant will remain in their allocated group throughout the study period, with no crossover between interventions. The parallel assignment model is chosen to allow direct comparison of the efficacy, safety, and adherence between the two dosing regimens while avoiding carryover effects, which are particularly relevant in treatments affecting serum ferritin and haemoglobin levels. The primary purpose of the study is treatment, and outcomes will be assessed through clinical evaluation and laboratory measurements over the 12 weeks follow-up period.

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

BU (2)