A Comparative Study Between Lactoferrin Versus Ferrous Sulfate in Iron-deficiency During Pregnancy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change in serum ferritin level
研究概览
简要总结
The main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. It has become very apparent gastrointestinal intolerance with oral iron therapy is dose related and common (up to 20% of patients), and this frequently leads to poor compliance.
Lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. It represents an attractive and promising alternative to ferrous sulphate oral administration as pregnant women receiving lactoferrin did not experience any adverse effects.
This study aims to compare between lactoferrin and ferrous sulphate for therapy of iron deficiency in pregnant women.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with single fetus.
- •Second trimester (14-20weeks of gestation).
- •Normal Hemoglobin level: more than10g\dl.
- •Serum ferritin less than 15 mcg / L
排除标准
- •Other type than iron-deficiency anemia (thalassemia, hemolytic anemia ... etc.)
- •Any other chronic diseases (bronchial asthma, renal or hepatic, hematological or cardiovascular diseases ... etc.)
- •Having hypersensitivity to iron preparations.
- •Treatment with any other iron preparation in the last month.
- •History of peptic ulcer, oesophagitis or hiatal hernia.
- •Medical disorders with pregnancy.
- •Need for alternative parenteral route to blood transfusion when rapid increase is required (perioperative anemia-severe anemia in late pregnancy-postpartum anemia) .
- •Bleeding in early pregnancy.
- •Refusal to participate in the study.
- •Family history of thalassemia-sickle cell anemia or malabsorption syndrome.
- •Recent blood transfusion.
- •Inflammatory bowel disease as intolerance of oral therapy but tolerated to parenteral route.
研究组 & 干预措施
Lactoferrin Group
Includes 49 pregnant women receiving lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin (R) , Hygint pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.
干预措施: Baseline ferritin level (Diagnostic Test)
Lactoferrin Group
Includes 49 pregnant women receiving lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin (R) , Hygint pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.
干预措施: Lactoferrin (Drug)
Lactoferrin Group
Includes 49 pregnant women receiving lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin (R) , Hygint pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.
干预措施: Follow up ferritin level (Diagnostic Test)
Ferrous Sulfate Group
Includes 49 pregnant women receiving 200 mg of dried ferrous sulfate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset (Feosol (R) , Meda pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.
干预措施: Baseline ferritin level (Diagnostic Test)
Ferrous Sulfate Group
Includes 49 pregnant women receiving 200 mg of dried ferrous sulfate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset (Feosol (R) , Meda pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.
干预措施: Ferrous Sulfate (Drug)
Ferrous Sulfate Group
Includes 49 pregnant women receiving 200 mg of dried ferrous sulfate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset (Feosol (R) , Meda pharmaceuticals). Baseline ferritin level will be obtained and compared to follow up ferritin level after 30 days of treatment.
干预措施: Follow up ferritin level (Diagnostic Test)
结局指标
主要结局
Change in serum ferritin level
时间窗: 4 weeks
Change in serum ferritin level between enrollment and 4 weeks post-treatment.
次要结局
- Nausea and/or vomiting(4 weeks)
- Dyspepsia(4 weeks)
- Compliance to treatment(4 weeks)
研究者
Ghada Mohamed Ahmed
Resident of O&G
Ain Shams University