Iron Bisglycinate Chelate or Ferrous Fumarate in Treatment of Iron Deficiency Anemia in Pregnant Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Hemoglobin level
研究概览
简要总结
Anemia in pregnancy is defined by the World Health Organization as hemoglobin levels of ≤ 11 g/dl. Globally, a prevalence rate of 38% was estimated by the World Health Organization for pregnant women.Treatment of iron deficiency anemia during pregnancy remains a main public health issue. Oral iron salts have been recommended for treatment of iron deficiency anemia e.g. ferrous fumarate. Increasing the dose of ferrous fumarate will subsequently increase the bioavailability of iron preparation, however it also increases the frequency of gastrointestinal tract side effects e.g. nausea, constipation, diarrhea, flatulence, and black stained stools. Besides, the increased bioavailable ferrous fumarate may decrease by many foods and / or chelating drugs in the gastrointestinal tract which interfere with its absorption leading to variability in the hemoglobin correction during the treatment.
Ferrous bisglycinate is an iron amino acid chelate. It is formed by reaction of ferrous iron with two molecules of the amino acid glycine by a covalent bound in a process called chelation. Ferrous bisglycinate is claimed to have better patient compliance because of fewer gastrointestinal tract side effects. It is also claimed that ferrous bisglycinate improves iron absorption, storage and increase hemoglobin level better than the conventionally used iron salts.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 20 to 40 years,
- •14-27 gestational weeks calculated from the first day of their last menstrual period and confirmed by ultrasound
- •Singleton fetus
- •hemoglobin level from 7-9.9 g/dL.
排除标准
- •All women with high risk pregnancy e.g. hypertension, diabetes
- •multiple pregnancy
- •women with severe anemia (Hb >7 g/dl)
- •anemia due to other causes than iron deficiency as chronic blood loss, hemolytic anemia or thalassemia.
- •women with hepatic, renal or cardiovascular abnormality; women with peptic ulcer, esophagitis, gastritis or hiatus hernia
- •family history of thalassemia, sickle cell anemia, or malabsorption syndrome
- •hypersensitivity to iron preparations or current use of iron supplementation.
研究组 & 干预措施
Group A
Iron bisglycinate (27mg of elemental iron)
干预措施: Iron bisglycinate Oral Tablet (Drug)
Group B
Ferrous fumarate (115mg of elemental iron)
干预措施: Ferrous Fumarate Oral Tablet (Drug)
结局指标
主要结局
Hemoglobin level
时间窗: At 4 weeks
次要结局
未报告次要终点
研究者
Hatem AbuHashim
Professor
Mansoura University
