NCT03212781已完成3 期
Total Dose Infusion of Iron Dextran Versus Oral Iron for Treating Iron Deficiency Anemia in Pregnant Women: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The change in Hemoglobin concentration from baseline to 8 weeks therapy
研究概览
简要总结
Iron deficiency is the most prevalent nutritional deficiency and the most common cause of anemia .It is characterized by a defect in hemoglobin synthesis, resulting in red blood cells that are abnormally small (microcytic) and contain a decreased amount of hemoglobin (hypochromic).
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hemoglobin < 10 g/dL
- •Gestational age between 14-28 weeks.
- •Willingness to participate and signing the informed consent form.
排除标准
- •Iron overload or disturbances in utilization of iron
- •Decompensated liver cirrhosis and active hepatitis
- •Active acute or chronic infections
- •History of multiple allergies
- •Known hypersensitivity to parenteral iron or any recipients in the investigation drug products
- •Erythropoietin treatment within 8 weeks prior to the screening visit
- •Other iron treatment or blood transfusion within 4 weeks prior to the screening visit
- •Planned elective surgery during the study.
研究组 & 干预措施
intravenous iron
Experimental
patients will receive intravenous iron as total dose infusion
干预措施: Iron dextran (Drug)
oral iron
Active Comparator
patients will receive oral iron
干预措施: Ferrous Fumarate (Drug)
结局指标
主要结局
The change in Hemoglobin concentration from baseline to 8 weeks therapy
时间窗: 8 weeks
measure hemoglobin level before and after treatment
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
Principal investigator
Assiut University
研究点 (1)
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