Alternate-day Versus Daily Oral Iron Therapy in Children With Iron Deficiency Anaemia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study alternate-day versus daily oral iron therapy in children with iron deficiency anaemia
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Six months to 12 years old children with iron deficiency anaemia
排除标准
- •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
研究组 & 干预措施
Alternate-day group
Alternate-day group receiving oral iron III polymaltose complex 3mg/kg/day
干预措施: Alternate-day oral Iron (III)-hydroxide polymaltose complex (Drug)
Alternate-day group
Alternate-day group receiving oral iron III polymaltose complex 3mg/kg/day
干预措施: Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing (Drug)
Daily group
Daily group receiving oral iron III polymaltose complex 3mg/kg/day
干预措施: Alternate-day oral Iron (III)-hydroxide polymaltose complex (Drug)
Daily group
Daily group receiving oral iron III polymaltose complex 3mg/kg/day
干预措施: Iron (III)-hydroxide polymaltose complex - daily oral dosing Iron (III)-hydroxide polymaltose complex - alternate-day oral dosing (Drug)
结局指标
主要结局
To study alternate-day versus daily oral iron therapy in children with iron deficiency anaemia
时间窗: 1 year duration
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
次要结局
- 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)
研究者
Dr Zayar Kyaw Win
Senior Consultant Paediatrician, Department of Paediatrics
University of Medicine, Mandalay