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Not yet recruiting NCT07391371

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

Phase IV Interventional Iron Deficiency Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alternate-day oral Iron (III)-hydroxide polymaltose complex, Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing.
Who it may be relevant to
Registry conditions: Iron Deficiency Anemia. Basic parameters: 6 months — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Burma
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Interventions

  • 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 i

Primary outcome measures

  • To study alternate-day versus daily oral iron therapy in children with iron deficiency anaemia [Time frame: 1 year duration]
Secondary outcome measures (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 [Time frame: one year duration]

Eligibility criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Burma · 2 centers
  • Paediatrics ward, 300 Beeded Teaching Hospital, Mandalay — Mandalay
  • Paediatrics ward, 300 Beeded Teaching Hospital, Mandalay — Mandalay

Identifiers

NCT: NCT07391371 · UMM-13(1/2025)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗