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临床试验/NCT02590224
NCT02590224已完成4 期

Ferrous Bis-glycinate Versus Ferrous Glycine Sulfate for the Treatment of Iron Deficiency Anemia During Pregnancy

Assiut University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
1
主要终点
the rate of increase of Hemoglobin level

研究概览

简要总结

Iron deficiency anemia during pregnancy is a significant worldwide health problem, affecting 22% of pregnant women in industrialized countries and 52% in non-industrialized countries. Iron deficiency anemia during pregnancy is associated with increased maternal as well as fetal morbidity, including prematurity, low birth-weight and perinatal and infant loss. Therefore, routine iron supplementation during the second half of pregnancy has been recommended once daily. Others, however, support a selective iron supplementation only for women with iron deficiency anemia, in order to avoid the increased risk of haemoconcentration associated with routine iron supplementation. Unfortunately, compliance to either iron-supplementation programs, especially among pregnant women, is poor, due in part to the side effects associated with these preparations.

Currently, there are many iron preparations available containing different types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug reactions found with these preparations are mainly gastrointestinal intolerance like nausea, vomiting, constipation, diarrhea, abdominal pain, while ferrous bis-glycinate (fully reacted chelated amino acid form of iron) rarely make complication.

Product resulting from the reaction of a metal ion from a soluble salt with amino acids to form coordinate covalent bonds, the resulting molecule is called as chelate and chemical bonding process is called chelation. Ferrous bis-glycinate is highly stable and totally nutritionally functional chelate it is an amino acid fully reacted chelate which is formed by the binding of two molecules of glycine to one Fe2+ atom.

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
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy.
  • Gestational age 14-18 weeks.
  • Mild to moderate anemia
  • No associated medical or obstetric complications.
  • Women not already receiving iron therapy.
  • Women accepted to participate in the study.

排除标准

  • Multiple pregnancy
  • Severe anemia
  • Iron hypersensitivity.
  • Liver diseases.
  • Women refuse to participate in the study.

研究组 & 干预措施

Ferrous bis-glycinate group

Active Comparator

The patients will receive oral ferrous bis-glycinate fully reacted amino acid 27 mg tablets (Pharaferro 27 tablets) once daily for eight consecutive weeks.

干预措施: Ferrous bis-glycinate (Drug)

Ferrous glycine sulphate group

Active Comparator

The patients will receive 567.6 mg of ferrous glycine sulphate capsules (Ferrosanol duodenale capsules, Schwarz) once daily for eight consecutive weeks.

干预措施: Ferrous glycine sulphate (Drug)

结局指标

主要结局

the rate of increase of Hemoglobin level

时间窗: 8 weeks

difference in hemoglobin concentrations before and after treatment

次要结局

未报告次要终点

研究者

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

Ahmed Mohamed Abbas

Dr

Assiut University

研究点 (1)

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