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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of Medicine, Mandalay

About this trial

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

Eligibility criteria

Qualifiers

None

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups