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

Обзор

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

Вмешательства

• Препарат 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)
• Препарат 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

Первичные конечные точки

• To study alternate-day versus daily oral iron therapy in children with iron deficiency anaemia [Срок оценки: 1 year duration]

Вторичные конечные точки (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 [Срок оценки: one year duration]

Критерии участия

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Burma · 2 центра

• Paediatrics ward, 300 Beeded Teaching Hospital, Mandalay — Mandalay
• Paediatrics ward, 300 Beeded Teaching Hospital, Mandalay — Mandalay

Идентификаторы

NCT: NCT07391371 · UMM-13(1/2025)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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