跳至主要内容
临床试验/NCT02076828
NCT02076828已完成不适用

Comparison of Ferrous Sulfate, Polymaltose Complex and Iron-zinc in Iron Deficiency Anemia

Hacettepe University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change from baseline in Hb levels at 2 months

研究概览

简要总结

The aim of the present study was to compare the effectiveness of the different oral iron preparations in children with IDA.

详细描述

Iron deficiency (ID) is the most common cause of the anemia throughout the world, with almost half of the population in developing countries suffering from ID. Children with iron deficiency anemia (IDA) may have functional consequences including impaired motor and physical growth. In the case of IDA, the underlying cause should be identified and treated. Iron supplementation remains an important strategy for the prevention and treatment of IDA and can produce substantial improvements in the functional performance of iron deficient individuals.

The iron-containing preparations available on the market vary widely in dosage, salt, and chemical state of iron (ferrous or ferric form). Current treatment strategy for IDA involves the oral use of Fe2+ salts (Fe SO4) and Fe3+ polymaltose complexes (FeOH3). Most of these preparations vary in their bioavailability, efficacy, side effects, and cost. Animal studies have not shown any significant difference in their oral bioavailability. However, in clinical practice, bivalent iron salts such as ferrous sulfate (Fe-S), ferrous gluconate, and ferrous fumarate are more widely used and are preferred over ferric iron preparations. Fe-S preparations usually present good bioavailability (between 10 and 15 %), while bioavailability of ferric iron preparations is 3 to 4 times less than that of conventional Fe-S. This is due to the extremely poor solubility of ferric iron in alkaline media and the fact that ferric iron needs to be transformed into ferrous iron before being absorbed. For this reason, among ferrous preparations, Fe-S remains the established and the standard treatment of ID due to its acceptable tolerability, high effectiveness, and low cost. The aim of the present study was to compare the effectiveness of the different oral iron preparations in children with IDA.

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 180 Months(Child)
性别
All
接受健康志愿者

入选标准

  • The children with IDA, aged between 6 months and 15 years, were randomly included in Fe-S (Ferro Sanol® sp.)(Group I), Fe-OH-PM (Santafer® sp.)(Group II), and Fe-Zn (Ferro Zinc® sp.)(Group III). IDA was defined as hemoglobin (Hgb), serum iron and ferritin levels below -2SD according to age and gender.

排除标准

  • The main exclusion criteria were anemia due to other causes except IDA
  • Severe concurrent illness (cardiovascular, renal, and hepatic)
  • Known hypersensitivity to ferrous or ferric preparations
  • Malignancy of any type
  • Children with thalassemia major, sickle cell anemia or other hemoglobinopathies, hemolytic anemia or aplastic or hypoplastic anemia.

研究组 & 干预措施

Fe-OH-PM (Santafer® sp.)(Group II)

Experimental

The patients in Group II were treated with Fe-OH-PM (Santafer® sp.), 6 mg/kg/day orally.

干预措施: Santafer® sp. (Drug)

Fe-Zn (Ferro Zinc® sp.)(Group III)

Experimental

The patients in Group III were treated with Fe-Zn (Ferro Zinc® sp.), 6 mg/kg/day orally

干预措施: Ferro Zinc® sp (Drug)

Fe-S (Ferro Sanol® sp.)(Group I)

Experimental

The patients in Group I were treated with Ferro Sanol® sp., 6 mg/kg/day orally

干预措施: Ferro Sanol® sp (Drug)

结局指标

主要结局

Change from baseline in Hb levels at 2 months

时间窗: 2 months

次要结局

  • Change from baseline in Iron levels at 2 months.(2 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin Ozsurekci

Pediatric Infectious Diseases Specialist

Hacettepe University

研究点 (1)

Loading locations...

相似试验