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临床试验/CTRI/2024/06/068424
CTRI/2024/06/068424尚未招募2 期

To assess the Efficacy of Microencapsulated Ferric Saccharate as a Novel Oral Iron Strip vs Colloidal Elemental Iron for treatment of Iron Deficiency Anemia in children- Randomized control trial

Jawaharlal Nehru Medical College KLE university Belagavi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月16日最近更新:

试验速览

阶段
2 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 assess the efficacy of microencapsulated ferrous saccharate vs colloidal elemental iron for treatment of iron deficiency anemia

研究概览

简要总结

Iron deficiency anemia (IDA) is a prevalent global health issue characterized by a deficiency of iron, a crucial micronutrient for erythropoiesis. This condition significantly impacts individuals of all ages, leading to fatigue, weakness, and impaired cognitive function. This study aims to explore the newer formulations in the treatment of iron deficiency anemia. Limitations of conventional iron salts have resulted in emergence of newer oral iron preparations like microencapsulated ferric saccharate, carbonyl iron, iron polymaltose complex, ferrous ascorbate, sodium feredetate and ferrous bisglycinate. The objective of oral iron strips used in iron deficiency anemia treatment is to provide a convenient and effective way to supplement iron. The micro-encapsulated iron AB-Fortis® presents a solution. In this unique technology, the iron is protected and kept stable by a natural, organic layer which avoids the release of free iron. As a result, there is no metallic taste, oxidation or negative gastrointestinal side effects. The oral strips offer an alternative to traditional iron supplements, such as tablets or capsules, and can be particularly beneficial for those who may have difficulty swallowing pills. The benefits of AB-Fortis iron is its uniform and defined dose, which is kept constant among batches, always around 40% of iron by weight and another crucial advantage of AB-Fortis is the minimal release of iron from the microcapsules during its storage, which prevents the classical side effects of the administration of free iron: metallic taste, dental darkening, abdominal pain, black feces and avoiding the oxidation of folic acid and omega-3 fatty acids.

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
5.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • children aged between 5-18 years of age diagnosed as iron deficiency anemia attending Inpatient & outpatient department in KLE’S Dr.Prabhakar Kore Hospital and Medical Research Centre, Belagavi.

排除标准

  • 1.Children aged less than 5 years because of increased chances of choking risk
  • Subjects Who are already on iron supplementation
  • Subjects with hypersensitivity to any of the ingredients of the product (such as lactose)
  • Children with severe anemia who are in need of parenteral supplementation.

结局指标

主要结局

To assess the efficacy of microencapsulated ferrous saccharate vs colloidal elemental iron for treatment of iron deficiency anemia

时间窗: Hemoglobin, MCV, MCH, MCHC, Iron profile is assessed at the time of diagnosis and at 3months after treatment

次要结局

  • To study the side effects & compliance of oral preparations(Side effects & compliance assessed at 1 month & at 3 months of follow up by asking questionnaire)

研究者

发起方
Jawaharlal Nehru Medical College KLE university Belagavi
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Kag Rakesh Choudhary

Jawaharlal Nehru Medical College

研究点 (1)

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