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临床试验/CTRI/2024/06/068445
CTRI/2024/06/068445已完成不适用

Comparison of the Effectiveness between Liposomal Iron and Conventional Iron in the Treatment of Iron Deficiency Anaemia - A Randomised Control Trial

Dr Suresh R1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年6月11日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
To Compare the effectiveness between Liposomal Iron, Iron Polymaltose complex and Ferrous Ascorbate.

研究概览

简要总结

Study Hypothesis : Can the Liposomal Iron cause a quicker response and better tolerance as compared to conventional Iron?

Study Justification :  Iron deficiency Anaemia is more prevalent among growing children and the Iron formulations usually has adverse effects such as constipation, diarrhoea and unpleasant taste and it leads to poor compliance and hence the study aims to compare the effectiveness between conventional Iron and Liposomal Iron with regards to clinical response , oral tolerability and side effect profile.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Month(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Children with Mild to Moderate Iron Deficiency Anaemia Children with no other haematological disorders Children not started on any iron supplements in last 3 months children without any active infections.

排除标准

  • Children who are already on treatment Children with other medical condition.

结局指标

主要结局

To Compare the effectiveness between Liposomal Iron, Iron Polymaltose complex and Ferrous Ascorbate.

时间窗: At the time of diagnosis and one month after treatment

次要结局

  • To Compare the oral tolerability and side effect profile between liposomal Iron, Iron polymaltose complex and Ferrous Ascorbate(At one month after treatment)

研究者

发起方
Dr Suresh R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Suresh R

SRM Medical College Hospital and Research Centre

研究点 (1)

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