Lactoferrin Versus Ferrous Fumarate for Treatment of Mild to Moderate Iron Deficiency Anemia During Pregnancy
试验速览
- 阶段
- 1 期
- 入组人数
- 150
- 主要终点
- Increase in blood hemoglobin.
研究概览
简要总结
This study will conducted to evaluate and comparison between the effectiveness, safety and acceptability of lactoferrin alone, ferrous fumarate alone and combination of both for the treatment of mild to moderate IDA during pregnancy.
详细描述
Anemia in pregnancy is a major public health problem, where it has been estimated that 41.8% of pregnant women worldwide are anemic .
Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. IDA develops when available iron is insufficient to support normal red cell production and is the most common type of anemia Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis.
The daily requirement of iron is around 1.5 mg in nonpregnant women. This requirement increases dramatically during pregnancy to reach 6-7 mg/day (total 1000 mg) with advanced gestational age. Pregnancy causes a twofold to threefold increase in the requirement for iron and a 10- to 20-fold increase in folate requirement. The increase in demand for iron is mainly due to fetal requirement, placenta, blood volume, tissue accretion, and the intra-partum potential for blood loss
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
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women from 24-36 weeks of gestation.
- •Mild to moderate anemia.
排除标准
- •Women with a history of anemia due to any other causes other than IDA.
- •Severe anemia requiring blood transfusion.
- •History of peptic ulcer.
- •known hypersensitivity to iron preparations.
研究组 & 干预措施
Oral lactoferrin
women who take oral lactoferrin sachets 100 mg twice daily for one month.
干预措施: Lactoferrin and ferrous fumarate (Drug)
Oral ferrous fumarate
women who take oral ferrous fumarate tablet 30 mg elemental iron twice daily for one month.
干预措施: Lactoferrin and ferrous fumarate (Drug)
Combined lactoferrin & ferrous fumarate
women who take lactoferrin sachets 100 mg and ferrous fumarate tablet 30 mg elemental iron once daily for one month.
干预措施: Lactoferrin and ferrous fumarate (Drug)
结局指标
主要结局
Increase in blood hemoglobin.
时间窗: one month
mean difference in hemoglobin level between pre treatment and post treatment.
次要结局
未报告次要终点
研究者
Amaal Khalil Hamed
principal investigator
Assiut University